Wellness Foods & Supplements 3/2020

Wellness Foods & Supplements is the first European magazine devoted exclusively to health ingredients, nutraceutical foods and beverages.

Wellness Foods & Supplements is the first European magazine devoted exclusively to health ingredients, nutraceutical foods and beverages.


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No. 3, November/December <strong>2020</strong><br />

www.harnisch.com | ISSN 2364-8104<br />

Nutrition and ageing Functional sugars Oils and fats Energy and endurance<br />

Minerals Women’s health Clinical trials Dairy Fortified dairy alternatives

Editorial<br />

SILKE WATKINS, Editor-in-Chief<br />

Social contacts – an elixir of life?<br />

Normally, I would have written the editorial<br />

for this issue in the run-up to Fi Europe<br />

and Hi Europe and would have been looking<br />

forward to the talks at the fair. However,<br />

unfortunately, everything is different this year<br />

and we are now experiencing a second lockdown<br />

that encroaches deeply on our normal<br />

lives.<br />

Trade fairs have been cancelled and how<br />

long we will have to wait in order to be able<br />

to present ourselves at a trade fair again and<br />

to have personal discussions is currently not<br />

foreseeable.<br />

In the editorial of issue 1, I already dealt with<br />

how this exceptional situation affects older<br />

people in particular, who depend on contact<br />

with other people because it is so important<br />

for their mental health. Politicians in<br />

particular have repeatedly emphasised that<br />

we have to protect the elderly. One would<br />

assume that one would have learned from<br />

the consequences of the initial lockdown<br />

and developed concepts. Unfortunately, I<br />

see next to nothing of that. It is still said that<br />

we have to massively restrict our contacts.<br />

Doesn't that inevitably mean that relatives,<br />

friends and acquaintances are again banned<br />

from visiting senior citizens?<br />

appeal to politicians. So residents in retirement homes should not be<br />

isolated again. The appeal contains, among other things, a demand<br />

for the right of home residents and their relatives to social contact, a<br />

right to touch, a right to protective clothing, a right to pastoral care<br />

and a right to privacy.<br />

This should make it possible to reconcile the right to self-determination<br />

and the free development of the personality on the one hand with<br />

the protection of life in the homes on the other.<br />

I think this appeal is very important and right. With all the challenges,<br />

we must not forget that a healthy life also requires social contacts,<br />

such as a friendly conversation, a touch, an open ear or a helping<br />

hand.<br />

In this issue, you will find out what we can do about our health in<br />

terms of nutrition or strengthening our immune system. I wish you an<br />

interesting read and a better year 2021.<br />

With kind regards<br />

Silke Watkins<br />

I just learned from the local press that<br />

pastors and old people's home chaplains<br />

are watching the stricter visiting rules in the<br />

homes with concern. They have made an<br />

No. 3 November/December <strong>2020</strong><br />


Contents<br />

Health<br />

Convenience Food<br />

Food & Beverages<br />

Confectionary<br />

Cover Photo © : AdobeStock/iONYXprj<br />

The number and proportion of people aged 60 years<br />

and older in the population is increasing. In 2019,<br />

the number of people aged 60 years and older was<br />

1 billion. This number will increase to 1.4 billion by<br />

2030 and 2.1 billion by 2050. Nowadays seniors<br />

actively seek to maintain good health in everyday<br />

life. Healthy ageing is the process of “developing<br />

and maintaining the functional ability that<br />

enables wellbeing in older age”. Seniors have<br />

specific nutritional needs (proteins, calcium,<br />

etc.) as they are more exposed to health issues.<br />

Despite this, they do not want to feel categorized<br />

and nutritional products must be indulgent and<br />

attractive.(see article at page 12)<br />

Sports Nutrition<br />

Health Care<br />

Contents<br />

Personal Care<br />

Oils and fats<br />

06 Keeping omega-3 oils safe, pure and taste-neutral<br />

Functional sugars<br />

10 Human milk oligosaccharides for health<br />

Nutrition and ageing<br />

12 Outstanding milk proteins & bioactives, allies of seniors<br />

Energy and endurance<br />

17 Be your best with Bioactive Collagen Peptides ®<br />

Minerals<br />

20 Magnesium Carbonate – Oldie but Goldie<br />

Women’s health<br />

23 Her ally for a healthy intimate flora<br />

Clinical trials<br />

28 Adaptive designs in clinical trials: when, why and how?<br />

Fortified dairy alternatives<br />

32 Mineral fortification in dairy alternatives<br />

Dairy products<br />

39 Yogurt Powders: the health benefits of yogurt with added convenience<br />

42 Impressum<br />

4 No. 3 November/December <strong>2020</strong>



L. plantarum ROSELLA is<br />

L. plantarum P17630 (Proge P17630 ® ),<br />

licensed from PROGE FARM ® , Italy.<br />



Oils and fats<br />

Photo © : 123rf/jirkaejc<br />

Keeping omega-3 oils safe, pure<br />

and taste-neutral<br />

Frank Möllering<br />

With the growing awareness of the health benefits of omega-3<br />

unsaturated fatty acids, demand for supplements, fortified<br />

foods and enriched beverages is rising. High-quality vegetable<br />

and microalgae-derived oils are particularly popular,<br />

but consumers are still sceptical about omega-3 products<br />

containing fish oil. Straight away, “fishy” smelling and<br />

tasting capsules come to mind. Yet, there are methods and<br />

processes available that refineries can use to supply highpurity<br />

oils that are absolutely neutral in terms of sensory<br />

properties.<br />

Although the number of people who still abide by the old dietary<br />

recommendation of eating fish at least once a week is declining,<br />

there is increasing evidence to illustrate just how important omega-3<br />

fatty acids are for our minds and bodies. For a long time, fatty fish<br />

and seafood such as mussels were said to be the most important<br />

sources; now, however, a huge array of dietary supplements are available<br />

on the market, and a growing number of<br />

foodstuffs and beverages are enriched with<br />

essential fatty acids. Fish is still a popular<br />

source of oil, but it’s a challenging material<br />

to process: it oxidises quickly and, like<br />

any crude oil of plant or animal origin, can<br />

become contaminated during cultivation<br />

or transport. Additionally, fish oil poses the<br />

greatest challenge in terms of neutralising<br />

its fishy odour and taste. Nutriswiss, a small<br />

refinery that specialises in purifying and<br />

modifying high-quality edible oils, has been<br />

processing fish oil for many years. Keeping<br />

a close eye on market developments at the<br />

same time, this Swiss company is well aware<br />

of the plant-based trend and now processes<br />

just as much algal oil as fish oil.<br />

6 No. 3 November/December <strong>2020</strong>

Oils and fats<br />

Growing demand for health<br />

and wellness<br />

To ensure a sufficient supply of essential fatty<br />

acids, alternatives to fish oil are in demand.<br />

In recent years, vegetable sources such as<br />

nuts, seeds and oils (such as rapeseed)<br />

have become increasingly popular; chia<br />

and linseed are frequently used as toppings<br />

in healthy bowls or shakes, for example.<br />

Compared with marine sources, they mainly<br />

contain the omega-3 fatty acid, ALA (alphalinolenic<br />

acid), which must be converted by<br />

human metabolism to DHA (docosahexaenoic<br />

acid) and EPA (eicosapentaenoic acid).<br />

As this is only partially possible and an inefficient<br />

process, the required intake is much<br />

higher.<br />

Long-chain omega-3 fatty acids play an<br />

important role in brain growth and development,<br />

blood pressure regulation, kidney function,<br />

blood clotting and numerous inflammatory<br />

and immunological reactions. A recent<br />

study showed that omega-3s can protect the<br />

brain from the damage caused by inhaled<br />

particulate matter. 1 As a component of cell<br />

membranes, the unsaturated fatty acids<br />

in breast milk, especially DHA, are important<br />

for healthy eye and brain development,<br />

particularly during the first two years of life.<br />

And as the body of scientific proof expands,<br />

so too do the regulatory requirements: DHA<br />

must now be present at a concentration of<br />

20–50 mg per 100 kcal in any infant formula<br />

that’s to be sold in the EU. 2<br />

smell). But, it’s not just sensory properties that make a good omega-3<br />

oil, purity is also crucial.<br />

The higher the proportion of unsaturated fatty acids in a raw oil,<br />

the more carefully it needs to be handled. On one hand, both the<br />

crude and refined oils must be protected and kept within a controlled<br />

atmosphere; on the other, it means that harsh refining environments<br />

need to be avoided. The chemical structures of omega-3 fatty acids<br />

contain several double bonds, which is why they react very quickly.<br />

For sources with extremely high omega-3 contents, such as tuna oil,<br />

which contains 25 % DHA, the oxidation potential is correspondingly<br />

high. It is too unstable to be refined in the same way that rapeseed or<br />

soy oil is, for example. At the same time, though, any contaminants<br />

that are harmful to health must be refined out to comply with food<br />

safety standards.<br />

Microalgae<br />

Many companies have now realised that microalgae can serve as a<br />

sustainable alternative raw material: they are relatively easy to cultivate<br />

and reproduce quickly (Fig. 1). For instance, the food industry<br />

considers them to be a productive marine source of omega-3. As<br />

they comprise up to 50 % fat, refining the raw oil is very efficient and,<br />

almost as importantly, they contain EPA and even more DHA than<br />

tuna oil. Fish does, too, but they get it from consuming algae — so<br />

why not start directly at the source? In addition, algae cultures are<br />

more environmentally friendly and protect fish stocks. Although the<br />

microalgae market is still in the discovery phase, growers and refiners<br />

such as Nutriswiss are already ahead of the curve and are driving<br />

further research and product development with algae oil.<br />

Sensory properties correlate with quality<br />

Optimising the sensory properties of omega-3 oils means more than<br />

just consumer acceptance; unpleasant off notes and a bad odour<br />

are symptoms of a decaying product. At Nutriswiss, a comprehen-<br />

High risk of oxidation<br />

Once the extracted oils are microencapsulated<br />

or powdered, the valuable fatty acids<br />

are completely isolated, which makes<br />

further decomposition reactions less likely.<br />

Most food operators understand that when<br />

handling oils containing polyunsaturated<br />

fatty acids, an oxidation reaction takes place<br />

when they come into contact with oxygen<br />

in the ambient air, which induces decomposition.<br />

The consequences clearly manifest<br />

themselves as off notes, an unappealing<br />

taste and a dark colour (mainly because of<br />

the formation of ketones and aldehydes that<br />

are responsible for that all-too-familiar fishy<br />

Fig.1: In the food and nutraceuticals industry, and beyond, microalgae are<br />

the new all-rounders. (Photo © : 123rf/Akhararat Wathanasing)<br />

No. 3 November/December <strong>2020</strong><br />


Oils and fats<br />

sive “key figure” profile is initially compiled for each oil in the factory’s<br />

own analytical laboratory. This determines how much “damage”<br />

has already occurred. Key factors such as the anisidine value, which<br />

measures the secondary degradation products of lipid-compound<br />

oxidation — such as aldehydes — provide information about the<br />

history of the raw material. After the refining process, the analyses<br />

are repeated: the removal of secondary oxidation products makes it<br />

possible to reduce the anisidine value in fish oil to less than 10 and,<br />

in some cases, less than 5, which corresponds to premium quality.<br />

Figures such as these are responsible for the company’s excellent<br />

reputation worldwide, especially as a supplier of high-purity oils and<br />

specialities for a wide range of sectors, including food, infant formula<br />

and pharmaceuticals.<br />

Contaminants<br />

Oxidation products are not the only compounds that have to be<br />

removed from a crude oil by refining. Owing to their apolar structure,<br />

lipids are especially susceptible to environmental contaminants.<br />

Oils from plants often accumulate the insecticides, fungicides and<br />

herbicides used in traditional cultivation. In addition, mineral oil saturated<br />

hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons<br />

(MOAH) – originating from exhaust gases or emissions from industrial<br />

facilities, among other sources – may have been transferred to the<br />

raw oil during processing and packaging. Marine animals are particularly<br />

at risk: other than cultivated (fermented) algae, which grow in<br />

tanks in a closed system, they are at risk of accumulating pesticides<br />

that might be present in the ocean.<br />

As with almost all sensitive natural raw materials, the challenge is<br />

implementing a gentle purification process that preserves the valuable<br />

polyunsaturated fatty acids. To remove certain contaminants,<br />

high temperatures are normally required, which actually promotes<br />

the formation of other contaminants (trans fatty acids and chlorinefatty<br />

acid esters such as 3-MCPD, for example). For 3-MCPD, in<br />

particular, more stringent regulations are due to come into effect in<br />

the EU for infant foods in January 2021. And, tighter restrictions are<br />

also being considered for other residues and applications.<br />

Choosing a gentle process<br />

Refining processes that work well for other vegetable oils operate at<br />

temperatures of 180–250 °C. As this would be an excessive thermal<br />

load for omega-3 oils, Nutriswiss has established a system to both<br />

maximise the yield and minimise the level of contaminants. At the<br />

centre of this technique is short path distillation (SPD), a particularly<br />

gentle physical separation process that is already well-established in<br />

the fish oil industry (Fig.2). Equipped with additional process technology,<br />

it is the procedure of choice for difficult-to-process raw materials,<br />

those that are heavily contaminated or when an extremely pure<br />

end product is required (baby food, for example). With the help of a<br />

finely controlled vacuum (with a pressure of less than 0.01 mbar) and<br />

short residence times, the thermal load on the product is significantly<br />

Fig. 2: The strength of short path distillation is that it is gentle on unsaturated<br />

fatty acids and yet provides effective purification. (Photo © : Nutriswiss)<br />

reduced, which minimises the formation<br />

of process contaminants. At the same<br />

time, free fatty acids, plasticisers and pesticides<br />

are removed to an extent that cannot<br />

be achieved with conventional technology.<br />

MOSH/MOAH levels can also be significantly<br />

reduced.<br />

Subsequently, the sensory quality can be<br />

further optimised by adding various absorbents<br />

– such as activated carbon – before the<br />

deodori sation stage. The final refining steps<br />

are only done directly before delivery to keep<br />

the storage times short and to prevent oxidation<br />

as far as possible. In the end, even volatile<br />

fish oils arrive with a completely neutral<br />

taste and odour, and look just like rapeseed<br />

oil with a light-yellow colouring.<br />

Welcome to the neutral zone<br />

Even though taste and quality are more<br />

closely linked to omega-3 oils than some<br />

other products, Nutriswiss insists on the<br />

very best conditions, right from the start.<br />

No matter whether the extract is derived<br />

from fish or algae or plants, the end result is<br />

sensorial neutrality. To facilitate this, carefully<br />

controlled and selected raw material sourcing<br />

is essential. As such, longstanding collaborations<br />

with suppliers and independent<br />

inspectors, coupled with the company’s own<br />

sealed food-grade containers, which protect<br />

the raw materials from contact with foreign<br />

materials and ambient oxygen, ensure the<br />

best possible outcome. In addition, before<br />

8 No. 3 November/December <strong>2020</strong>

Oils and fats<br />

production starts, each process and method is tested in the laboratory,<br />

so that all procedures and methods can be adapted to suit<br />

individual applications. To ensure that the key data and sensory<br />

profile information meet the requirements for pharmaceutical or<br />

special nutrition products, the refining steps are carefully planned<br />

and monitored. For instance, the composition of a baby food formulation,<br />

including the optimum ratio of omega-3 and omega-6, can be<br />

developed according to specific customer requirements. Afterwards,<br />

scale-up – from small quantities of around 500 kg batches of several<br />

tons – can be done, which can be particularly interesting when<br />

developing novel foods and other specialities. In fact, the process<br />

is so successful that when a member of the research team baked a<br />

Gugelhupf (yeast based) cake with fish oil instead of baking fat for his<br />

children, they didn’t notice any difference.<br />

References<br />

1<br />

Cheng Chen et al. (<strong>2020</strong>): Erythrocyte omega-3 index, ambient fine particles exposure and<br />

brain aging, Neurology Vol. 95 (8). https://n.neurology.org/content/95/8/e995. Accessed 9<br />

October <strong>2020</strong><br />

2<br />

Delegated Regulation (EU) 2016/127 of the Commission of 25 September 2015.<br />

https://eur-lex.europa.eu/eli/reg_del/2016/127/oj/deu. Accessed 14 October <strong>2020</strong><br />

Among others, Nutriswiss processes the following omega-3<br />

crude oils:<br />

Fish oil, Algae oil, Rapeseed oil/canola oil, Linseed oil, Hemp oil,<br />

Walnut oil, Chia oil, Perilla oil<br />

The refined or modified oil can then be delivered in:<br />

Bags-in-Boxes, Containers, Cartons and cups, Bottles, Barrels<br />

The omega-3 oils can be used in the following applications:<br />

Infant formula (powdered or spray-dried), any fortified foodstuff such<br />

as dairy products or soft drinks, Pharmaceuticals<br />

(encapsulated)<br />

For more information, please contact<br />

Frank Möllering<br />

Head of R&D, Nutriswiss AG,<br />

Industriering 30, CH-3250 Lyss<br />

Phone (central): +41 32 387 48 48<br />

info@nutriswiss.ch<br />

www.nutriswiss.ch<br />

SKIN<br />

BEAUTY<br />


Rond-Point Georges Jolimaître - BP 259 - 81305 Graulhet Cedex - FRANCE<br />

Tel : + 33 (0)5 63 42 14 41 / welcome@weishardt.com<br />


Enjoy the benefits of Naticol ® ,<br />

a natural and unique ingredient in<br />

anti-aging products for daily use.<br />

/ Bioactive ingredient<br />

/ Clinically proven<br />

/ Water soluble<br />

/ Pure protein (>99%, DM)<br />

/ Distributed worldwide<br />

WEIGHT<br />


Fish Collagen Peptides

Functional sugars<br />

Photo © : Jennewein Biotechnologie<br />

Human milk oligosaccharides for health<br />

Dr. Bettina Gutiérrez<br />

Human milk oligosaccharides (HMOs) are functional sugars<br />

who have some important health benefits. The German<br />

company Jennewein Biotechnologie is producing these<br />

complex sugars in an industrial scale.<br />

Already at the end of the 19 th century, the Austrian paediatrician<br />

Theodor Escherich recognised that breastfed children had a<br />

7 times higher chance of survival than non-breastfed children. When<br />

researching the causes of this, human milk oligosaccharides (HMOs)<br />

were discovered in the breast milk. This means that it was discovered<br />

that these functional sugars, which are the third most significant<br />

components of breast milk after fats and lactose, are responsible for<br />

the well-being of infants. Later, in the '50s, '60s and '70s, scientists<br />

researched the characterisation of these HMOs, which are structurally<br />

diverse. There are around 200 types. In the '90s, their biologi cal<br />

and nutritional properties were researched. Scientific studies<br />

discovered that they have health benefits for both infants and adults.<br />

As an example, they protect against infections, are prebiotic, stabilise<br />

the immune system, prevent allergies and promote a healthy microbiome<br />

and the neuronal development.<br />

However, until recently, it was not possible to produce these<br />

HMOs in industrial scale to make them available to all. Jennewein<br />

Biotechnologie, a German company, took on this task: With the help<br />

of a self-developed fermentation process, they have succeeded in<br />

producing these sugar molecules on such a scale. This process is<br />

based on the bacteria strain E.coli BL21, which is genetically modified<br />

by the biotechnologists so that these bacteria produce the enzymes<br />

necessary to form HMOs. Since 2016 the most common oligosaccharide<br />

2’-fucosyllactose (2’-FL) has been supplied as a nutritional<br />

supplement to well-known baby food manufacturers in the USA, and<br />

since 2017 in Europe. For mothers who cannot breastfeed, this is a<br />

relief as their babies can now also benefit from the positive effects<br />

of breast milk. 2'-fucosyllactose is, like the other biotechnological<br />

produced HMOs chemically identical to its natural models in breast<br />

milk. It occurs in almost 80 % of all milk samples at a concentration<br />

of 3 g/l and has mainly the characteristics to ward off pathogens and<br />

promote a healthy gut microbiome.<br />

The product portfolio of the company includes, in addition to 2'-FL,<br />

amongst others the HMOs 3-fucosyllactose, lacto-N-tetraose, 3'-sialyllactose,<br />

6'-sialyllactose and the monosaccharides L-fucose and sialic<br />

acid (NANA). In addition to the specific benefits of these polysaccharides,<br />

they have an anti-adhesive effect in infants and adults, which<br />

means that they can prevent pathogens from entering the body cells<br />

of infants and adults. Most HMOs resemble the structure on the<br />

intestinal cells to which the pathogens bind. Due to this similarity,<br />

they can act as deceptive receptors by binding them to themselves,<br />

which prevents them from binding to the host cell, eliminating the<br />

pathogens from the intestine. This means they can inhibit an infection<br />

with viral and bacterial pathogens. As an example, 2'-fucosyllactose<br />

and 3-fucosyllactose protect against norovirus and rotavirus<br />

infections. Researchers from the company participated recently in a<br />

study entitled “Biotechnologically produced fucosylated oligosaccharides<br />

inhibit the binding of human noroviruses to their natural<br />

receptors” published in the well-known Journal of Biotechnology,<br />

10 No. 3 November/December <strong>2020</strong>

Functional sugars<br />

which is dedicated to this protective effect of<br />

HMOs. “Complex oligosaccharides such as<br />

HMOs can mimic the structure of the virus’<br />

natural receptor on human cells, coating<br />

the virus and preventing it from interacting<br />

with targets. We demonstrated this ability for<br />

2’-FL and 3-FL in our previous study in 2016.<br />

But the development of more complex oligosaccharides,<br />

which mimic the virus receptors<br />

even more closely, allows us to significantly<br />

improve this protective effect” states<br />

Dr. Katja Parschat, Co-Head of R&D at<br />

Jennewein Biotechnologie.”In this new study<br />

we included additional HMOs such as lacto-<br />

N-fucopentaose I and even more complex<br />

oligosaccharides” she adds.<br />

The company now wants to launch a new<br />

product generation with a 5'-HMO mix which<br />

comes even closer to the model of natural<br />

breast milk and consists of the five most<br />

common HMOs in natural concentrations:<br />

2'-fucosyllactose, 3-fucosyllactose, lacto-Ntetraose,<br />

3'-sialyllactose and 6'-sialyllactose.<br />

It is the first product to contain both neutral<br />

and acidic HMOs. In order to test whether<br />

this mix is well tolerated by infants and can<br />

guarantee the necessary safety requirements<br />

for approval in the EU, Jennewein<br />

Biotechnologie launched a clinical study<br />

in December 2018. This study was carried<br />

out in hospitals in Spain, Italy and Germany.<br />

324 babies divided into three groups were<br />

tested. The first interim results point to good<br />

tolerability of HMOs; the final results are<br />

expected at the end of this year.<br />

In addition to this mix, there are also other matters that point to a<br />

successful future and new market opportunities. In the future,<br />

further research on metabolic engineering and the microbiome<br />

will take place at the company’s new R&D centre in Bonn. The<br />

research work on the microbiome targets the development of products<br />

in the “healthy microbiomes” sector in baby and infant food.<br />

And in September of this year, the company was acquired by the<br />

Chr. Hansen Holding A/S, based in Hoersholm in Denmark.<br />

Chr. Hansen is a leading bioscience company that develops natural<br />

ingredients solutions for the food, nutritional, pharmaceutical and<br />

agricultural industries. The company produces cultures, enzymes,<br />

probiotics and natural colours for a variety of foods, confectionery,<br />

beverages, dietary supplements, animal feed and plant protection<br />

and has a profound experience in the fermentation technology. This<br />

means, that the strengths of Jennewein Biotechnologie and Chr.<br />

Hansen in the pre- and synbio tic market will be combined. And, that<br />

they will join their forces in a more and more growing global human<br />

milk oligosaccharides market.<br />

For more information, please contact<br />

Dr. Bettina Gutiérrez,<br />

press and public relations,<br />

Jennewein Biotechnologie,<br />

Part of Chr. Hansen Group<br />


Nutrition and ageing<br />

Photo © : Adobe Stock/pressmaster<br />

Outstanding milk proteins & bioactives,<br />

allies of seniors<br />

Sandrine Tran & Elsa Trotier<br />

Introduction<br />

The global population is ageing rapidly as it is projected to double in<br />

30 years.<br />

Senior population projection to 2050 1<br />

Nowadays seniors actively seek to maintain<br />

good health in everyday life. Healthy ageing<br />

is the process of “developing and maintaining<br />

the functional ability that enables<br />

wellbeing in older age” 2 .<br />

Population<br />

Today<br />

929<br />

million<br />

+ 60<br />

years old<br />

Seniors have specific nutritional needs<br />

(proteins, calcium, etc.) as they are more<br />

exposed to health issues. Despite this, they<br />

do not want to feel categorized and nutritional<br />

products must be indulgent and attractive.<br />

The ageing population market<br />

2050<br />

2<br />

billion<br />

By 2050, WHO projects that 434 million people will be 80 or older<br />

Seniors can be defined as aged from 50 to<br />

65 according to countries (WHO, <strong>2020</strong>).<br />

Older population can be considered as the<br />

elderly. Two types of nutrition exist on the<br />

ageing population market: the senior nutrition<br />

and the geriatric nutrition.<br />

12 No. 3 November/December <strong>2020</strong>

Nutrition and ageing<br />

The senior nutrition<br />

The senior nutrition includes food supplements<br />

or functional food used as prevention<br />

to stay healthy and to prevent diseases<br />

among seniors and elderly people.<br />

It aims to accompany them to improve their well-being and prevent<br />

undernutrition. It is part of the clinical nutrition.<br />

The elderly’s protein and calcium needs<br />

It is mandatory to provide enough proteins to the body in order to<br />

increase the muscular protein synthesis.<br />

3, 4, 5<br />

Elderly people’s nutritional needs: recommended protein intake<br />

Elderly nutritional needs<br />

Adults<br />

Elderly<br />

Market data of the senior nutrition<br />

(Euromonitor, <strong>2020</strong>)<br />

Since 2017, the senior market has been<br />

expanding tremendously. During the<br />

past year, most launched senior-destined<br />

products were high protein milk and dietary<br />

supplements. They were mainly sold in<br />

China and 93 % of the launched products<br />

have a “senior (age 55+)” claim on<br />

packagings. In Europe, such claims are very<br />

few, as the population is less inclined to feel<br />

labeled (Mintel, <strong>2020</strong>).<br />

42 % of the senior nutrition products have<br />

more than 10 % of proteins and 14 % of<br />

them have a “high protein” claim (Mintel,<br />

<strong>2020</strong>).<br />

The geriatric nutrition<br />

The geriatric nutrition targets elderly people<br />

who have diseases or are undernourished.<br />

1st<br />

segment<br />

clinical<br />

nutrition<br />

H E L P T H R O U G H<br />

T H E I L L N E S S<br />

Geriatric<br />

nutrition<br />

market<br />

11.6<br />

USD<br />

billion<br />

Market data of the geriatric nutrition<br />

(Euromonitor, <strong>2020</strong>)<br />

Protein<br />

intake<br />

0.83g/kg/d<br />

A sufficient protein intake is necessary to maintain normal<br />

body functions<br />

* 1.2 times more than average adults<br />

** 1.6 times more than average adults<br />

In good health<br />

Protein<br />

intake<br />

1 - 1.2g/kg/d*<br />

Undernourished elderly people need a protein intake 50 % to 88 %<br />

superior to healthy adults but usually have low appetite. They also<br />

need a 1200 mg of calcium intake per day (EFSA, 2015; International<br />

Osteoporosis foundation).<br />

Seniors, prone to develop complications and<br />

diseases with age<br />

Undernourished<br />

Protein<br />

intake<br />

1.2 - 1.5g/kg/d**<br />

Undernutrition and sarcopenia<br />

One is undernourished if the BMI (Body Mass Index) is less than 21.<br />

It is recommended for an undernourished elderly person to avoid<br />

long fasting periods, such as night fasting (more than 12 hours a<br />

day), and to have a protein and energy enriched diet. 6<br />

Undernutrition is directly linked to muscle degradation. It aggravates<br />

sarcopenia, which is the reduction of muscular mass and physi cal<br />

abilities that eventually appear from 40 to 50. 7, 8 The leucine, an<br />

essential amino acid, is also important to trigger muscle synthesis<br />

9, 10<br />

with a necessary quantity of 2–-3 g among elderly people.<br />

To delay complications and avoid undernutrition when being older,<br />

prevention is recommended for seniors.<br />

Osteopenia<br />

After the age of 50, developing osteopenia (progressive bone weakening)<br />

is common. The aim is to strengthen bone mass to delay osteoporosis<br />

as much as possible. Osteoporosis corresponds to bone<br />

No. 3 November/December <strong>2020</strong><br />


Nutrition and ageing<br />

demineralization as the BMD (Bone mineralization density) lies 2.5<br />

points lower to standard values for young women. 11 Sarcopenia and<br />

osteopenia can both lead to mobility problems.<br />

+<br />

Proteins<br />

are needed<br />

for muscle<br />

synthesis<br />

Micellar Calcium highly bioavailable<br />

Prodiet ® Micellar caseins contain 2.6 % of<br />

highly bioavailable micellar calcium thanks<br />

to its dairy origin. “Slow” and “fast” proteins<br />

have a specific metabolism in postprandial<br />

conditions: 13,14<br />

Bone mass loss<br />

Bones become<br />

weaker<br />

(risk of fractures)<br />

Osteopenia<br />

Sarcopenia<br />

Muscle<br />

mass loss<br />

+<br />

Bones<br />

contain<br />

proteins<br />

Preventing sarcopenia and osteopenia among the elderly<br />

Other complications<br />

Indulgent and convenient nutritional products are important as loss of<br />

senses gradually increases like dysphagia and dysgeusia. Weakening<br />

of organ functions also lead to immune deficiencies and age is also<br />

one of the risk factors to develop type II diabetes. 12<br />

It is important to adapt seniors’ food with proper nutritional intakes,<br />

e. g. by consuming milk proteins. Besides, 56 % of seniors aged 60+<br />

declared that they consume dairy proteins as a source of protein<br />

intake (Euromonitor, <strong>2020</strong>).<br />

Ingredia’s proteins and bioactives as allies of seniors<br />

and the elderly<br />

For 70 years, the Group Prospérité Fermière – INGREDIA has<br />

specialized in dairy proteins and bioactives coming directly from its<br />

fresh milk collection.<br />

Micellar casein: a unique protein for senior and geriatric nutrition<br />

Micellar Caseins (92 % micellar caseins/8 % soluble proteins) are<br />

native proteins organized in micelles with a micellar calcium skeleton.<br />

The baseline depicts the continuously<br />

present amino acids in blood. Above means<br />

there is protein synthesis, below means<br />

avoiding protein breakdown is necessary.<br />

As they are slow proteins, micellar caseins<br />

can help to avoid muscle mass degradation<br />

and night fasting. Indeed, the amino acids<br />

are slowly released and can be digested up<br />

to 7 hours after ingestion. Oppositely, soluble<br />

proteins or whey proteins are fast proteins.<br />

Micellar caseins, an excellent<br />

amino acids profile<br />

Micellar caseins are particularly adapted<br />

for clinical nutrition. They have a higher<br />

chemi cal index* (146) compared to the<br />

FAO** protein reference (100).<br />

They are rich in all of the essential amino<br />

acids (EAA) (~43.5 %), in branched chain<br />

amino acids (BCAA) (~20.3 %) and in<br />

leucine (~9.2 %) for muscle synthesis.<br />

*Chemical index (CI): reveals the aptitude of<br />

the analysed protein to contain all the necessary<br />

amino acids.<br />

**FAO: Food and Agriculture Organization.<br />

Model of Caseins Micelle (Dalgleish, 2012)<br />

Prodiet ® Fluid, a micellar casein for highprotein<br />

beverages<br />

Prodiet ® Fluid is a micellar casein that<br />

contains more than 87 % of proteins on dry<br />

14 No. 3 November/December <strong>2020</strong>

Nutrition and ageing<br />

matter. It is the perfect solution to develop<br />

high protein beverages for seniors, as it<br />

provides a high content of leucine and an<br />

incredible fluidity up to 14 % of proteins,<br />

facilitating swallowing. The final product is<br />

stable for UHT and retort treatments, has a<br />

smooth texture and a delicious milky taste.<br />

For more information, please visit our<br />

website: https://www.prodiet-fluid.com/<br />

Protein hydrolysates, for faster absorption<br />

Protein hydrolysates are hydrolyzed peptides<br />

and amino acids that are faster absorbed by<br />

the organism, compared to intact proteins.<br />

Their amino acids are quickly available and<br />

have a great interest for clinical nutrition:<br />

they allow a quick activation of the peak of<br />

leucine, triggering muscle synthesis.<br />

Aminight, a beverage against overnight<br />

fasting with Prodiet ® Fluid and Prodiet ®<br />

Hydrolysate:<br />

Aminight is a high protein beverage with 12 % of proteins and 3.6 g<br />

of leucine. It limits elderly people’s overnight fasting, thanks to the<br />

combination of micellar caseins that reduce fasting periods, and whey<br />

protein hydrolysates for muscle synthesis thanks to the leucine peak.<br />

Bioactives, as nutritional protein solutions<br />

Osteum TM CPP, a calcium binding bioactive, to solidify bones<br />

Osteum TM CPP is a bioactive produced from native micellar caseins.<br />

It has a high calcium level that reaches more than 2 % and provides<br />

35 % of CPP (Casein phosphopeptides): they improve the calcium<br />

bioavailability and thus bone mineralization. Osteum TM CPP is an<br />

excellent ally to prevent osteopenia. Moreover, a study has shown<br />

that dairy CPP have a higher calcium binding capacity than the ones<br />

derived from acid precipitated caseins. 15<br />

Move up, a high protein milk drink to prevent sarcopenia<br />

and osteopenia<br />

Products aiming to prevent sarcopenia are fewer on the senior nutrition<br />

market than bone health products. Move up is an indulgent high<br />

protein milk drink for seniors, formulated to prevent sarcopenia and<br />

osteopenia. It contains both Prodiet ® Fluid and Osteum TM CPP, a very<br />

interesting combination as they have complementary functions for<br />

senior nutrition. It is rich in micellar calcium with 566 mg*/serving.<br />

*68 % of the Daily Recommended Intake of calcium.<br />

Your<br />

Magnesium<br />

all-rounder<br />

Magnesium Carbonate<br />

always fits<br />

◆ Various bulk densities available<br />

◆ DC grades for direct compression<br />

◆ Perfect for Magnesium fortification and as food additive<br />

◆ High Magnesium content ideal for muscle,<br />

nerve and bone concepts

Nutrition and ageing<br />

Proferrin ® , an outstanding immuno-modulator<br />

With age, seniors’ immune system efficacy naturally decreases.<br />

Proferrin ® is a natural lactoferrin coming from milk. It can be used<br />

for numerous benefits such as limiting infections, stimulating the<br />

immune system and enhancing gut health. 16<br />

Pep2dia ® , for delaying the onset of type II diabetes<br />

Pep2dia ® is a milk hydrolysate containing an active dipeptide, specifically<br />

designed for prediabetics. They have high blood sugar levels<br />

and risk to develop type II diabetes. Age, overweight, lack of physical<br />

activity are aggravating risks of developing diabetes 17 , and health<br />

conscious seniors can prevent it efficiently by combining good life<br />

hygiene and supplements such as Pep2dia ® .<br />

Conclusion<br />

The senior market keeps expanding, following the growing demand.<br />

Preventing seniors’ and the elderly’s health issues means maintaining<br />

their well-being longer.<br />

Micellar caseins are rich in calcium which limits osteopenia by<br />

increasing bone mineralization. With their high level in leucine, they<br />

can be used in products to prevent sarcopenia.<br />

Simultaneously, using a high-protein product<br />

with bioactives can become a real ally to<br />

healthy ageing. These ingredients are key for<br />

new senior products developments.<br />

Why choose milk protein<br />

High in<br />

essential<br />

Amino Acids*<br />

High<br />

nutritional<br />

quality<br />

Milky<br />

taste<br />

High in<br />

Leucine**<br />

reasons<br />

?6<br />

why<br />

High in<br />

micellar<br />

calcium<br />

Convenient<br />

for many<br />

applications***<br />

* Essential amino acids cannot be made by the body. As a result, they must come from food.<br />

** Necessary essential amino acid to trigger muscle synthesis (2-3g of Leucine)<br />

*** High protein drinks, pudding, yogurts, bars, shakes, finger foods...<br />

References<br />

1<br />

WHO, 2019.<br />

2<br />

WHO, <strong>2020</strong>.<br />

3<br />

ANSES, 2016. Saisine n° 2012-SA-0186 « Contribution des macronutriments à l’AET».<br />

4<br />

Bauer et al. 2013. Stratégie de prise en charge en cas de dénutrition protéino-énergétique chez la personne âgée, HAS, 2015. J Am Med Dir Asso<br />

5<br />

Réseau Espace Santé Cancer, 2015. Prise en charge du risque nutritionnel et de la dénutrition chez le patient atteint de cancer.<br />

6<br />

L’Assurance Maladie, 2015. Dénutrition chez la personne agée (> 70 ans) et aide à la prescription des Compléments Nutritionnels Oraux (CNO). Pp. 1-2.<br />

7<br />

Paddon-Jones D., Leidy H., 2014<br />

8<br />

Marzetti E., et al., 2017<br />

9<br />

Christos S. Katsanos et al., 2006<br />

10<br />

Hope Barkoukis, 2016<br />

11<br />

WHO, 2002. Proposed working definition of an older person in Africa for the MDS Project.<br />

12<br />

National Institute on Aging, 2019. Diabetes in older people.<br />

13<br />

Dangin, Boirie et al. 2001. The digestion rate of protein is an independant regulating factor of postprandial protein retention. Am J Physiol Endocrinol<br />

Metab.<br />

14<br />

Lacroix et al. 2006. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino<br />

acid requirement. Am J Clin Nutr.<br />

15<br />

T.Ono et al., 1998.<br />

16<br />

Zimecki M et al. 1999<br />

17<br />

Diabetes UK, 2019. Diabetes risk factors.<br />

For more information, please contact<br />

Elsa Trotier & Sandrine Tran,<br />

product managers Health and Nutrition<br />

e.trotier@ingredia.com<br />

s.tran@ingredia.com<br />

51 Av Lobbedez – CS 60946<br />

62033 Arras Cedex, France<br />

www.ingredia.com<br />

16 No. 3 November/December <strong>2020</strong>

Energy and endurance<br />

Photo ® : Stokkete/Shutterstock<br />

Be your best with<br />

Bioactive Collagen Peptides ®<br />

Innovative ingredients support collagenous “white tissue” and help athletes to get back<br />

to their performance levels after strain-related tendon issues<br />

Oliver Wolf<br />

Whether it’s skiing, running, ball games or<br />

even e-sports: All athletes need to deliver a<br />

consistently strong performance on a regular<br />

basis. Yet this means they often put their<br />

bodies under a lot of strain – which inevitably<br />

takes its toll physically. For instance,<br />

overused tendons are among the most<br />

common sports-related injuries suffered by<br />

athletes, be they amateur or professional. Yet<br />

there is a quick and easy way to help reduce<br />

the risk of such problems – supplementation<br />

with specific Bioactive Collagen Peptides ®<br />

TENDOFORTE ® from GELITA, which are<br />

proven to stimulate collagen-producing cells<br />

in tendons and ligaments.<br />

Product concepts with real benefits<br />

Collagen is the most abundant protein in the human body, making<br />

up 30 per cent of total protein content. It can be found in body parts<br />

such as bones, joints, ligaments, fascia or muscles – all of which<br />

are important for physically active people. There are a few reasons<br />

why collagen breakdown may outperform synthesis in sports, overuse<br />

being the main one. With its Bioactive Collagen Peptides ® , GELITA<br />

provides an optimal ingredient option for manufacturers who want to<br />

capitalise on the sports nutrition market, and create product concepts<br />

with real benefits for active consumers.<br />

To understand why collagen supplementation is so vital – especially<br />

for athletes – it’s important to look at the relationship between<br />

so-called white tissue and muscles. The whole musculoskeletal<br />

No. 3 November/December <strong>2020</strong><br />


Energy and endurance<br />

system is connected and protected by a network of connective tissue,<br />

comprising muscle fascia, tendons, ligaments, cartilage, bone and<br />

skin. Collectively known as “white tissue”, this network is formed<br />

mainly by collagen. Yet most people don’t think about white tissue<br />

until it becomes stressed and strained. This can result in back pain,<br />

Achilles tendon pain, ankle sprains, plantar fasciitis, patella tendon<br />

pain and ACL (anterior cruciate ligament) tears or IT band (iliotibial<br />

band) issues – like aching, burning, or tenderness on the outside of<br />

the knee. The white tissue supports the whole muscular system, it<br />

has an equally high rate of tissue turnover, and its own amino acid<br />

needs. Collagen is the main component of white tissue, and supplementation<br />

with Bioactive Collagen Peptides ® attends to the specific<br />

needs of the white tissues that are highly recruited in physical activity,<br />

giving structure to the whole body and supporting physical mobility.<br />

Improving muscle functions<br />

Muscles are made primarily of contractile material – otherwise known<br />

as “red tissue”. Therefore, it’s perhaps no surprise that most of the<br />

existing science and nutrition solutions – and manufacturers of<br />

sports nutrition – have so far focused on the contractile properties of<br />

muscles. But now, there are new scientific insights on muscles and<br />

their functions.<br />

Muscles are different from many other tissues in the way that their<br />

contractile fibres are enclosed in layers of collagen-rich white tissue<br />

– called the muscle fascia – a skin-like casing that influences muscle<br />

function. The fascia facilitates muscle contraction, which then<br />

engages the joint, including tendons and ligaments, ensuring the<br />

mechanical forces between muscles and bones create optimal movement<br />

(Millward and Smith, 2019). What this means? Muscles are so<br />

much more than “red tissue”. They are a remarkably effective combination<br />

of red contractile material with the white tissue network, as well<br />

as blood vessels and nerves – a fusion that strongly contributes to<br />

muscle function, growth and performance (Gillies and Lieber, 2011).<br />

“Almost every activity-related injury and its manifestations, such as pain,<br />

are to some extent linked to the white tissue, as well as an injured athlete’s<br />

ability to quickly return to play.” Photo ® : adimas/Fotolia<br />

The white tissue plays many other roles in<br />

muscle health and performance too. It bears<br />

most of the muscle load, so that a person’s<br />

range of motion primarily reflects their white<br />

tissue properties. Also, nearly every activityrelated<br />

injury and its manifestations, such as<br />

pain, are to some extent linked to the white<br />

tissue, as well as an injured athlete’s ability to<br />

quickly return to play.<br />

Scientifically proven<br />

Many manufacturers in the sports nutrition<br />

field are actively seeking ingredient options<br />

to create products for consumers who want<br />

to tackle sports-related injuries, or enhance<br />

their overall performance. GELITA, the<br />

leading manufacturer of collagen peptides,<br />

has created scientifically proven specific<br />

Bioactive Collagen Peptides ® that optimally<br />

stimulate white tissue cells to produce new<br />

collagen matrix proteins. This helps athletes<br />

train at high intensity, while remaining injuryfree.<br />

A speedier return to training<br />

Regular intake of collagen peptides can help<br />

boost collagen production and, in sports<br />

nutrition, to reduce activity-induced tendon<br />

problems is a real need state. Research has<br />

shown that the specific Bioactive Collagen<br />

Peptides ® found in TENDOFORTE ® stimulate<br />

the RNA expression and biosynthesis<br />

of collagen, proteoglycans and elastin in<br />

Achilles tendons. This was proven by an<br />

Australian study that found subjects with<br />

long-term symptoms of chronic Achilles<br />

tendinopathy were able to return to running<br />

within three months when supplementing<br />

their diet with TENDOFORTE ® , and were<br />

able to keep running for the remainder of the<br />

trial period. Research has also demonstrated<br />

that oral ingestion of the specific collagen<br />

peptides improves the extension properties<br />

of finger joints.<br />

In Germany, researchers at the University<br />

of Freiburg Department of Sport examined<br />

the role of TENDOFORTE ® in reducing ankle<br />

sprains and improving ankle stability. They<br />

concluded that six months’ supplementation<br />

with TENDOFORTE ® resulted in significant<br />

18 No. 3 November/December <strong>2020</strong>

Energy and endurance<br />

improvements in ankle stability, reduced<br />

sprains and a reduced risk of further injury in<br />

the three-month follow-up period, suggesting<br />

that its effects are long-term (Dressler et al.,<br />

2018).<br />

So, by taking TENDOFORTE ® , athletes<br />

can avoid strain-related tendon issues. In<br />

addition, these specific peptides can help<br />

athletes make a quicker return to training, at<br />

previous performance levels.<br />

Consumer appeal<br />

The ability of Bioactive Collagen Peptides ® to<br />

deliver a targeted health benefit is linked to<br />

the profile of peptides in the product, characterized<br />

by specific molecular weight distribution.<br />

The Bioactive Collagen Peptides ®<br />

can deliver benefits at a relatively low daily<br />

dose, which is crucial for successful finished<br />

product applications, formulation efficiency<br />

and consumer acceptance. Ultimately,<br />

the GELITA range of Bioactive Collagen<br />

Peptides ® enables a variety of finished<br />

product concepts, supported by productspecific<br />

science.<br />

As well as TENDOFORTE ® , the GELITA Bioactive<br />

Collagen Peptides ® portfolio also includes<br />

FORTIGEL ® , which is proven to stimulate joint<br />

cartilage regeneration; FORTIBONE ® which<br />

contributes to bone health by promoting the<br />

biosynthesis of the extracellular bone matrix,<br />

and BODYBALANCE ® , which improves<br />

body toning by helping to increase muscle<br />

mass while reducing body fat. With targeted<br />

marketing, these innovative ingredients<br />

can contribute to exciting new sports nutrition<br />

products that will appeal to the growing<br />

numbers of consumers with a keen interest<br />

in this market.<br />

For more information, please contact<br />

Oliver Wolf<br />

Head of B2B Marketing (Global)<br />

Global Marketing & Communication<br />


Uferstr. 7, 69412 Eberbach, Germany<br />

www.GELITA.com<br />

No. 3 November/December <strong>2020</strong><br />


Minerals<br />

Photo ® : Adobe Stock/nd3000<br />

Magnesium Carbonate – Oldie but Goldie<br />

Physiology and requirements<br />

Without the vitally important element Magnesium, it is impossible for<br />

living cells to fulfill their manifold physiological functions. Magnesium<br />

is of central importance in almost all metabolic processes and essential<br />

for the neuromuscular and cardiovascular system. A sufficient<br />

supply of Magnesium is important throughout lifetime – especially<br />

during pregnancy, childhood and old age. People in these phases<br />

of life and people with certain diseases have an increased need for<br />

Magnesium.<br />

The fortification of foods with Magnesium Carbonate or the use of food<br />

supplements can prevent a deficiency. With a Magnesium content of<br />

approx. 25 %, Magnesium Carbonate is an ideal source of Magnesium.<br />

It can be a good option for the prevention and therapy of a<br />

variety of different diseases. In Europe, the Nutrient Reference Value<br />

(NRV) for the daily intake of Magnesium is<br />

375 mg/d for adults. It is advantageous to<br />

have a continuous supply with Magnesium<br />

throughout the day.<br />

Magnesium Carbonate is an inorganic<br />

Magnesium Salt and is also known as the<br />

Magnesium Salt of carbonic acid. The natural<br />

form of Magnesium Carbonate (magnesite/<br />

bitter spar/magnesia alba) is beside Dolomite<br />

the most important Magnesium mineral on<br />

earth.<br />

Described and mostly naturally occurring<br />

forms of Magnesium Carbonate are, among<br />

others:<br />

Variations Chemical Formula Assay<br />

Magnesite MgCO 3<br />

28.8 % Mg, 71.2 % Carbonate<br />

Barringtonite MgCO 3<br />

*2H 2<br />

O 20.9 % Mg, 51.6 % Carbonate, 27.5 % Water<br />

Nesquehonite MgCO 3<br />

*3H 2<br />

O 18.4 % Mg, 45.4 % Carbonate, 36.3 % Water<br />

Lansfordite MgCO 3<br />

*5H 2<br />

O 14.8 % Mg, 36.5 % Carbonate, 48.7 % Water<br />

Artinit Mg 5<br />

(OH) 2<br />

(CO 3<br />

) 4<br />

*3H 2<br />

O 27.5 % Mg, 54.4 % Carbonate, 18.1 % Water/Hydroxide<br />

Hydromagnesite Mg 5<br />

(OH) 2<br />

(CO 3<br />

) 4<br />

*4H 2<br />

O 26.6 % Mg, 52.5 % Carbonate, 21.0 % Water/Hydroxide<br />

Dypingite/Giorgiosite Mg 5<br />

(OH) 2<br />

(CO 3<br />

) 4<br />

*5H 2<br />

O 25.7 % Mg, 50.7 % Carbonate, 23.7 % Water/Hydroxide<br />

Prokovskite Mg 2<br />

CO 3<br />

(OH) 2<br />

34.6 % Mg, 42.7 % Carbonate, 22.8 % Hydroxide<br />

20 No. 3 November/December <strong>2020</strong>

Minerals<br />

Dr. Paul Lohmann ® produces a highpurity<br />

and extremely versatile Magnesium<br />

Carbonate for miscellaneous applications. It<br />

meets the purity requirements of Ph. Eur.,<br />

USP, FCC and E 504 and offers an excellent<br />

stability. Customized requirements can be<br />

taken into account during production, as well.<br />

purity and nutritional value. Dr. Paul Lohmann ® has developed qualities<br />

that meet extra low heavy metal limits. Of course, our Magnesium<br />

Carbonate is also Kosher/Halal.<br />

The high quality standards and the focus on approval in pharmaceutical<br />

applications have proven their worth: Dr. Paul Lohmann ® was<br />

one of the first manufacturers of Magnesium Carbonate to receive the<br />

General properties and documentation<br />

Name:<br />

Magnesium Hydroxide Carbonate; Magnesium Carbonate, basic<br />

Formula:<br />

approx. 4MgCO 3<br />

*Mg(OH) 2<br />

*5H 2<br />

O<br />

Molecular weight:<br />

approx. 485 g/mol<br />

Appearance:<br />

white powder<br />

Odor:<br />

neutral<br />

Flavor:<br />

sandy, neutral<br />

Solubility (20 °C):<br />

< 1 g in 100 ml water<br />

pH (1% Suspension): approx. 10 (basic)<br />

Assay Magnesium (Mg): approx. 25 %<br />

Monographs of the European and American<br />

Pharmacopoeias (Ph. Eur., USP) describe<br />

Magnesium Carbonate as a basic Magnesium<br />

Carbonate containing crystalline water,<br />

which contains a certain amount of alkaline<br />

earth oxide, calculated as Magnesium Oxide.<br />

The Ph. Eur. also distinguishes a light and a<br />

heavy quality of Magnesium Carbonate. It is<br />

a white powder or granules.<br />

The bioavailable Magnesium Salt is almost<br />

insoluble in water but easily soluble in<br />

combination with acids, releasing CO 2<br />

. In<br />

contrast to soluble Magnesium Salts, an up<br />

to five times lower amount of the Mineral<br />

Salt is needed to obtain the same amount of<br />

Magnesium in the final product. This minimizes<br />

costs and enables various positioning<br />

possibilities in the field of food supplements,<br />

at the same time.<br />

Magnesium Carbonate is a fine white powder<br />

and available in different types. Depending<br />

on the application, an extra light (approx.<br />

65 g/l) or extra heavy quality (500 g/l) can<br />

be used. As granules, it is ideal for direct<br />

compression to tablets.<br />

In the GMP and DIN EN ISO certified production<br />

facilities, Magnesium Carbonates are<br />

produced which meet the highest possible<br />

quality criteria in terms of product safety,<br />

certificate of suitability (CEP/CoS) for its product as an active pharmaceutical<br />

ingredient (API) according to the European Pharmacopoeia<br />

from the European Directorate for the Quality of Medicines (EDQM).<br />

For the submission of pharmaceuticals to the health authorities, a<br />

detailed documentation of the active ingredient is required. In order<br />

to simplify this for customers, Dr. Paul Lohmann ® provides the corresponding<br />

CEPs (Certificate of Suitability to the European Pharmacopeia)<br />

for both light and heavy quality.<br />

Manufacturing<br />

Seventy percent of the world’s supply of Magnesium raw material is<br />

mined and processed in China. However, due to its sustainable orientation<br />

and extremely high purity requirements, Dr. Paul Lohmann ®<br />

has always used sources from European regions. Partnerships with<br />

mining companies, responsible mining and an active recultivation<br />

and renaturation program are the focus of attention.<br />

Environmental protection and the certainty to process raw materials<br />

of the highest quality requirements, allow us to guarantee that<br />

Magnesium Carbonates with the highest quality are produced in a<br />

unique synthesis process.<br />

In a special manufacturing process, different grades of Magnesium<br />

Carbonate are produced at the two production sites in northern<br />

Germany under strict safety and quality requirements. This is a<br />

continu ous process with maximum precision. The Magnesium<br />

Carbonate basic ensures the highest purity in the final product.<br />

By varying the manufacturing conditions, products with very different<br />

bulk densities can be obtained, and the purity of the individual<br />

No. 3 November/December <strong>2020</strong><br />


Minerals<br />

Health Claims<br />

Magnesium contributes to maintenance of important body functions:<br />

– Normal teeth and bones<br />

– Reduction of fatigue/tiredness<br />

– Normal muscle function<br />

– Functioning nervous system<br />

– Normal mental function<br />

– Energy metabolism<br />

– Protein synthesis<br />

– Normal electrolyte balance<br />

qualities is adjusted during the manufacturing process. In addition,<br />

customized services can be offered at the end of the manufacturing<br />

process. Directly compressible granules with different binding<br />

agents are examples of this. Due to their special properties, Dr. Paul<br />

Lohmann ® Magnesium Carbonates are in demand worldwide.<br />

Advantages of Dr. Paul Lohmann ® Magnesium Carbonate:<br />

– Known and constant Magnesium content, as defined<br />

– Constant composition<br />

– Controlled purity (absence of other elements)<br />

– Consistent, application-optimized density<br />

(filling volume/bulk density)<br />

– Reliable structure (grain size, morphology)<br />

– Assured solubility (e. g. effervescent tablets)<br />

– Uniform crystal structure<br />

Application areas<br />

Photo ® : Fotolia/alfa27<br />

With its high Magnesium content of about 25 %, Magnesium<br />

Carbonate is an extremely versatile product. Magnesium Carbonate<br />

is generally approved in the EU for food fortification and for the use<br />

in food supplements.<br />

Magnesium Carbonate is classically used to supplement Magnesium<br />

ions in e. g. effervescent tablets. Due to the multitude of physiologi cal<br />

functions that Magnesium performs in the body, manufacturers<br />

of food and food supplements have the opportunity to market the<br />

Magnesium Carbonate contained therein with correspondingly effective<br />

health claims. This becomes possible if the minimum requirements<br />

for a Magnesium source are met in accordance with the<br />

claim for the final product listed in the Annex to Regulation (EC) ​<br />

No 1924/2006.<br />

Magnesium Carbonate is harmless to health and therefore has no<br />

maximum level restriction as food additive E 504. As an acidity<br />

regulator, separating agent or filler, it is approved for all foods that<br />

may contain additives. This includes organic products as well. For<br />

example, it can show its pH-value stabilizing function in beverages<br />

and serve as a filler in tablet production.<br />

In the pharmaceutical sector, Magnesium Carbonate is used in pharmaceuticals<br />

for the regulation of gastric acidity (antacids), as a mild<br />

laxative or as a phosphate binder for the treatment of hyperphosphatemia.<br />

Due to its unique properties, Magnesium Carbonate is not only valued<br />

as a raw material in the pharmaceutical and food industries. It also<br />

shows technical advantages in the sports sector. Here Magnesium<br />

Carbonate is also sold under the names magnesia or chalk. It is used<br />

by apparatus gymnasts, strength athletes and climbers to absorb the<br />

sweat produced by their hands and thus increase the grip of their<br />

hands and the sliding ability on the apparatus spars. It can also be<br />

used in thermal insulation materials and as a filler in plastics, paper,<br />

paints and rubber, as well as in cosmetics in powder form.<br />

For more information, please contact<br />

Dr. Paul Lohmann GmbH & Co. KGaA<br />

Hauptstr. 2<br />

31860 Emmerthal, Germany<br />

sales@lohmann4minerals.com<br />

www.lohmann4minerals.com<br />

References<br />

1<br />

Commission Regulation (EU) No 432/2012 establishing a list of permitted health claims<br />

made on foods, other than those referring to the reduction of disease risk and to children’s<br />

development and health<br />

2<br />

Regulation (EC) No 1924/2006 or the European Parliament and of the Council on nutrition<br />

and health claims made on foods<br />

22 No. 3 November/December <strong>2020</strong>

Women‘s health<br />

Photo ® : Shutterstock/ESB Professional<br />

Her ally for a healthy intimate flora<br />

A convenient orally administered probiotic shown to support women’s intimate health<br />

Elodie Aragon and Marilou Luneau<br />

Probiotics for women’s health<br />

Over the past five years, the market for nutritional<br />

ingredients for women’s health carried<br />

on evolving to a more mature market, driven<br />

by consumers’ interest and research and<br />

development. With robust scientific backing<br />

and product development on the rise, global<br />

probiotic markets have been, in fact, growing<br />

fast for more than a decade. Lumina Intelligence<br />

confirms products have diversified<br />

from initial cores of gastro-intestinal health<br />

and immunity to a much broader range of<br />

benefits including skin, sports performance,<br />

brain health and more female-focused areas<br />

like vaginal health, urinary tract infections<br />

(UTIs), pregnancy and osteoporosis. Probiotics<br />

research and development is undeniably<br />

popular, with over 1600 ongoing human<br />

clini cal trials on probiotics listed in clinicaltrial.gov<br />

and WHO’s trial database.<br />

According to Grand View Research, the women’s health and beauty<br />

supplement market has reached $49.8 Billion in 2019 and the estimated<br />

compound annual growth rate (CAGR) for <strong>2020</strong> –2026 is<br />

4.75 %. The probiotics for women’s health core growth areas are:<br />

vaginal health, urinary tract infections, pregnancy and skin health.<br />

Among non-supplement women users, 40 % of them think their<br />

«feminine health issues» could be improved by using supplements.<br />

Probiotics for women’s health is a fast-growing market, increasingly<br />

attracting women through online and on-site retail places. Although<br />

women’s probiotic market used to be a niche market, it is now<br />

becoming a strong differentiation factor for product development,<br />

explaining why, since the past two years, a lot of new probiotic<br />

products target women, and consequently consumers online engagement<br />

is increasing: between December 2017 and January <strong>2020</strong> the<br />

number of reviews for women’s intimate health probiotics increased<br />

by 804 %, on average from the 20 countries studied. Specific probiotics<br />

are gaining attraction as they are a natural alternative to the<br />

conventional over-the-counter solutions for vaginal health. Women<br />

are willing to try them out especially when vaginal health conditions<br />

are recurrent, which alters general quality of life.<br />

No. 3 November/December <strong>2020</strong><br />


Women‘s health<br />

Probiotics for women’s health is a major opportunity to expand brand<br />

portfolios with a potential target audience of over 1.4 billion women.<br />

Genito-urinary issues, including vulvovaginal candidiasis, urinary<br />

tract infections and bacterial vaginosis are the leading conditions,<br />

bringing women to seek out medical advices, prescriptive drugs and<br />

to investigate natural efficient complementary supplements, such as<br />

probiotics.<br />

Lactobacilli: The gatekeepers of feminine health<br />

The female vaginal microflora is a rich and complex ecosystem,<br />

mainly consisting of Lactobacilli which support the vaginal environment<br />

and health. During her lifespan, every woman encounters<br />

specific health and well-being issues according to her lifestyle,<br />

physio logy, hormonal cycles and life stages. Vaginal balance is<br />

which incapacitates commensal bacteria.<br />

Candida albicans are also often found in the<br />

gastrointestinal tract, as part of a commensal<br />

bacteria. Candida can co-exist normally<br />

in the vagina without any problem, and a<br />

proper Candida albicans balance is an indicator<br />

of healthy vaginal microbiota. However,<br />

it may cause trouble if it outnumbers other<br />

microorganisms. Three out of four women<br />

will have an imbalance with a Candida albicans<br />

prominent microflora at some point in<br />

their life.<br />

How do probiotics promote vaginal<br />

health, even during times of occasional<br />

bacterial imbalance<br />

Lactobacilli can help rebalance the vaginal<br />

microflora and promote vaginal comfort<br />

during times of occasional vaginal imbalance.<br />

Lactobacilli probiotics, which have<br />

a positive effect on endogenous microflora<br />

could thus help support the vaginal microflora<br />

and protect against some undesirable<br />

bacteria.<br />

fragile, and many internal or external factors can affect this balance:<br />

gut health, immunity, mood balance, oral health, intimate health...<br />

they all have been linked by scientists to endogenous microbiota.<br />

Acting upon the gut or vaginal microbiota, specific probiotics can<br />

help each individual woman at every stage of her life, from puberty to<br />

menopause. The benefits of probiotics to support women’s health are<br />

increasingly recognised, mainly due to their ability to maintain and<br />

restore digestive and vaginal microflora balance, with positive consequences<br />

on feminine health as well as on digestive health, occasional<br />

stress or natural defenses. As per most of the beneficial effects of<br />

probio tics, the benefits on intimate health are not homogeneous for<br />

all the probio tics but are strain specific.<br />

What is the difference between bacterial vaginosis and<br />

vaginal yeast infection?<br />

Bacterial vaginosis<br />

is defined as a vaginal dysbiosis characterized by a decrease in<br />

concentration of Lactobacilli in the vagina and an increase in concentration<br />

of anaerobic bacteria such as Gardnerella vaginalis, Atopobium<br />

vaginae, Mycoplasma hominis, Prevotella, Porphyromonas. It<br />

is the most common vaginal infection in women of childbearing age.<br />

Vaginal yeast infection<br />

is also due to an imbalance in the vaginal flora. In this condition,<br />

the problem is a fungus called Candida, such as Candida albicans,<br />

24 No. 3 November/December <strong>2020</strong>

Women‘s health<br />

Meet women’s new best friend:<br />


To recolonize the vaginal microflora zone,<br />

choosing the right bacteria strain is crucial.<br />

Moreover, only a handful of probiotic supplements<br />

taken orally can do the trick. L. plantarum<br />

P17630 (Proge 17630 ® ), ROSELLA,<br />

is one of them.<br />

L. plantarum P17630 (Proge 17630 ® ),<br />

ROSELLA is a unique strain isolated from a<br />

healthy vaginal flora with full mechanistic and<br />

clinical evidence of efficacy on a wide spectrum<br />

of benefits, from helping to maintain<br />

proper vaginal balance, including from oral<br />

intake, to being used for recurrent Vulvovaginal<br />

Candidiasis (rVVC). This probio tic strain<br />

is one of the most documented in the world<br />

in the women’s health area, as it has been<br />

studied in over 800 women, in six clini cal<br />

studies, including two by oral intake. In<br />

combination or not with conventional treatments<br />

for candidiasis (anti-fungal) women<br />

saw an improvement in candidiasis with a decrease in symptoms<br />

including less swelling, redness, burning or itching infection that can<br />

be caused by an overgrowth of bad bacteria. This probiotic strain also<br />

helped reduce the risk of recurrence of this candidiasis*.<br />

ROSELLA is scientifically backed by mecha nistic data. Studies<br />

showed this specific strain was able to adhere and interfere with C.<br />

albicans (in vitro studies). It demonstrated vaginal colonization and<br />

persistence following oral intake (validated efficacy dose: 5B CFU/<br />

day).<br />

ROSELLA restores flora diversity associated with a healthy vaginal<br />

flora and promotes vaginal diversity associated with a healthy vaginal<br />

microbiota by normalizing pH. Furthermore, there are clinical<br />

evidences that this unique strain helps promote continued vaginal<br />

health in Vulvovaginal Candidiasis and in recurrent Vulvovaginal<br />

Candidiasis as adjunctive treatment with triazole or alone.<br />

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Women‘s health<br />

How can oral probiotics, after passage through the gut,<br />

have a beneficial impact on the vaginal microflora?<br />

Probiotics taken orally will pass through the gut, colonize the intestine<br />

and will be excreted in faeces. Anatomically, anus and vagina are<br />

very close, so naturally bacteria will pass and arrive in vagina in order<br />

to colonize it. This natural phenomenon occurs with “bad” bacteria<br />

causing infections like bacterial vaginosis, but also with “good”<br />

bacteria like probiotics. Gut to vagina passage was confirmed by clinical<br />

studies, in particular with ROSELLA which is found in vagina after<br />

oral intake. In Montella study, ROSELLA also showed persistence as<br />

ROSELLA was not only found in vagina after oral intake, but also after<br />

a 15 days wash-out period.<br />

Colonization of the vaginal microflora and persistence<br />

study in healthy women [Montella, 2013 and 2014]<br />

On 24 healthy women with a normal vaginal flora, an optimal oral<br />

intake dose was determined of 5B CFU/day with two cycles of 15<br />

days intake followed by 15 days washout among different dose and<br />

regimen. ROSELLA strain was identified by Polymerase Chain Reaction<br />

(PCR) with specific strain primers in both faecal and vaginal<br />

samples, even after a 15 days washout period, demonstrating the gut<br />

to vagina passage, colonization and persistence.<br />

Efficacy study in healthy women prone to experiencing<br />

temporary imbalances in their vaginal microflora<br />

[Vladareanu, 2018]<br />

Following the Montella pilot study<br />

confirming dose and safety, an efficacy<br />

study was conducted on 93 healthy women<br />

with recurrent vulvovaginal candidiasis<br />

enrolled during relapse-free period. These<br />

women took either ROSELLA (5B CFU/<br />

day) or a placebo during three cycles of 15<br />

days, followed by 15 days washout. At T0,<br />

around 60 % of women have an abnormal<br />

vaginal flora (LBG IIa to LBG III). In the<br />

ROSELLA group, there was a significant<br />

increase (p

Women‘s health<br />

[Nava 2002, results]<br />

In 2014, De Seta study results on pH normalization,<br />

increase of lactobacilli and improvement<br />

of symptoms, ROSELLA’S legiti macy<br />

was equally confirmed.<br />

In 2016, Cianci, in order to open indications,<br />

ROSELLA was tested in a pilot study<br />

on 94 women with bacterial vaginosis (BV)<br />

and aerobic vaginitis (AV). After 15 days, a<br />

signifi cant increase of reported clinical resolution<br />

was observed.<br />

Why maintaining vaginal pH balance is essential to<br />

keeping a healthy vaginal flora?<br />

The pH scale runs from 0 to 14. A pH of less than 7 is considered<br />

acidic, and a pH of more than 7 is basic. A normal vaginal pH level<br />

is between 3.8 and 4.5, which is moderately acidic. However, what<br />

constitutes a “normal” pH level can vary slightly during a women’s life<br />

due to internal changes, and many external factors can also modify the<br />

pH levels in this delicate zone. Whilst an acidic vaginal environment is<br />

protective and creates a barrier that prevents unhealthy bacteria and<br />

yeast from multiplying too quickly and causing infection, weak acid,<br />

or raised pH levels provides the perfect setting for unhealthy bacteria<br />

to develop, hence putting women at risk of contracting various more<br />

or less severe infections.<br />

For more information, please contact<br />

Lallemand Health Solutions<br />

HealthSolutions@Lallemand.com<br />

https://lallemand-healthsolutions.com/en/rosella/<br />

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www.harnisch.com/food/en/newsletter-sign-up<br />

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No. 3 November/December <strong>2020</strong><br />


Clinical trials<br />

Photo ® : Adobe Stock/Robert Wilson<br />

Adaptive designs in clinical trials:<br />

when, why and how?<br />

The use of dietary supplements and nutraceuticals has been<br />

constantly growing among people who are looking for ways to promote<br />

wellbeing and health. Additionally, their demand for clarity around the<br />

attributes on product labeling is on the rise. Particularly, they want<br />

to know that the products they are ingesting are safe and effective<br />

based on rigorous clinical evidence obtained from studies testing the<br />

same products. This shift of consumers’ attitude highlights the importance<br />

of well-designed and well-conducted clinical trials in building<br />

and growing market of the products. A clinical trial can be conducted<br />

to assess absorption/bioavailability active ingredients, safety or tolerance,<br />

and/or efficacy of product, as well as consumers’ acceptance<br />

and satisfaction of product. All information and clinical results gathered<br />

in clinical trials serve as a foundation for marketing and scientific<br />

communications, as well as regulatory requirements.<br />

Biofortis a CRO (Contract Research Organization) that is part of<br />

Mérieux NutriSciences, specializes in clinical services for nutraceutical<br />

and food products and has successfully completed over 250<br />

trials since 2002. Biofortis provides all expertise required for clinical<br />

study, ranging from scientific insights to fieldwork and data valorization<br />

needed to successfully manage international multicentric studies<br />

to assess bioavailability, efficacy, safety/tolerance.<br />

A team of scientists, statisticians and methodologists, focuses on<br />

each clients’ unique expectations and needs, and works to adapt<br />

persona lized, customized and robust designs. Traditionally, clini cal<br />

trials are run in three phases: design, execution, and data analysis.<br />

An alternative approach is the Adaptive<br />

Design trial which can be used to optimize<br />

the scientific data delivery and decrease cost<br />

and time to market, while still using robust<br />

and specific statistics models. The adaptive<br />

designs can be applied across all phases<br />

of clinical research, from early-phase dose<br />

response and safety designs to confirmatory<br />

trials.<br />

We interviewed two Biofortis experts; Hélène<br />

Chevallier (Clinical Methodologist) and<br />

Florence Gillaizeau (Senior Biostatistician),<br />

on the basics of adaptive design and why<br />

you could consider this for your future study<br />

with Biofortis.<br />

What is an adaptive design clinical trial?<br />

There is no universal definition of an adaptive<br />

design. As compared to traditional design<br />

trials, where you design, then you conduct<br />

the study, and finally you analyze the results,<br />

adaptive design is more flexible in that it<br />

allows the data to drive modifications of the<br />

original design (if scientifically justified and<br />

necessary) prior to the formal completion<br />

of the study. This clinical study design uses<br />

28 No. 3 November/December <strong>2020</strong>

Clinical trials<br />

accumulating data to decide how to modify<br />

certain aspects of the study without undermining<br />

the validity and integrity of the trial.<br />

After almost ten years since the first draft,<br />

the Food and Drug Administration (FDA)<br />

finally edited the final version of the “Adaptive<br />

Designs for Clinical Trials of Drugs and<br />

Biologics Guidance for Industry” last year<br />

(FDA, November 2019). In this guidance,<br />

the following definition is used: “an adaptive<br />

design is defined as a clinical trial design<br />

that allows for prospectively planned modifications<br />

to one or more aspects of the<br />

design based on accumulating data from<br />

subjects in the trial”.<br />

There are some main concepts common<br />

to all the references that discuss adaptive<br />

designs. First, during the study, every single<br />

modification needs to be prospectively<br />

planned into the protocol. After reviewing<br />

results of data analysis, usually through an<br />

interim analysis, with full control of the type I<br />

error (which means the control of the risk of<br />

a false positive conclusion), some modifications<br />

including but not limited to, changes<br />

to the sample size and population or premature<br />

discontinuation of one study arm, can<br />

be implemented. According to the FDA guidance,<br />

the interim analysis is defined as “any<br />

examination of data obtained from subjects<br />

in a trial while that trial is ongoing”. The<br />

analysis can be done in a fully blinded procedure<br />

or unblinded procedure.<br />

Could you explain more specifically the<br />

interim analyses?<br />

According to the International Council for<br />

Harmonisation of Technical Requirements<br />

for Pharmaceuticals for Human Use (ICH),<br />

involving regulatory members (e. g. the European<br />

Commission, the US FDA, the Ministry<br />

of Health, Labour and Welfare of Japan)<br />

and industry Members (e. g. the Pharmaceutical<br />

Research and Manufacturers of<br />

America), an interim analysis is any analysis<br />

intended to compare treatment arms<br />

with respect to efficacy or safety at any time<br />

prior to the formal completion of a trial. The<br />

results are prepared by an independent statistician<br />

(other than the study statistician)<br />

and reported to an independent Data Monitoring<br />

Committee (DMC) that recommends to the sponsor whether<br />

to continue, modify or stop the trial. The DMC members must have<br />

no financial or intellectual conflicts of interests in the outcome of the<br />

study. Therefore, the participation of employees of the sponsor in this<br />

committee is discouraged. DMCs typically include clinicians and at<br />

least one biostatistician with expertise in clinical trial and interim data<br />

analysis.<br />

To avoid introducing bias into ensuing study design, conduct or interpretation,<br />

all interim analyses are carefully planned and described in<br />

the protocol and it is strongly recommended to maintain interim analysis<br />

blind for investigators, sponsors or anyone outside DMCs.<br />

Are there different kinds of adaptive design?<br />

There are several types of adaptive designs and more than one can<br />

be applied to the same trial. Below is a summary of the most common<br />

types.<br />

Fig. 1 : Different types of adaptive designs<br />

Adaptive designs are applicable to both early and confirmatory clinical<br />

trials. Adaptive designs for early clinical trials such as the Continual<br />

Reassessment Method (CRM) and seamless designs deal mainly<br />

with establishing safe and effective doses or dose–response relationships.<br />

The CRM aims to identify the dose with optimal efficacy/<br />

response and is more accurate in estimating the maximum tolerable<br />

dose compared to a conventional design. Meanwhile, a seamless<br />

adaptive design combines two phases traditionally carried out in<br />

separate trials into one single study.<br />

Based on the review of interim results, change(s) to a study can<br />

occur in different development phases. For example, an adaptive<br />

randomization design involves shifting study participant allocation<br />

ratio towards more promising or informative treatment(s); an enrichment<br />

or subgroup design allows for adjustments to the recruitment<br />

of a specific subgroups based on efficacy endpoint; a group sequential<br />

design may lead to the premature termination of a trial based<br />

on efficacy, safety, and futility endpoints; adaptive-hypotheses design<br />

allows for changes in hypotheses, study endpoints and/or statistical<br />

No. 3 November/December <strong>2020</strong><br />


Clinical trials<br />

methods; and the sample size reassessment permits sample size<br />

adjustments to achieve a desired power.<br />

According to a review of Bothwell and colleagues (2018) which<br />

reviewed 142 adaptive design clinical trials published between 1978<br />

and 2014, the most popular adaptive designs used are the seamless<br />

designs (mainly combining phase II and III; i.e., Seamless IIb/III),<br />

followed by the group sequential design, and finally the enrichment<br />

or subgroups design.<br />

Could you describe the three most popular adaptive designs, highlighting<br />

the advantages and challenges?<br />

Seamless design II/III<br />

Fig. 2: Seamless phase II/III adaptive design, also called “drop the losers or<br />

pick the winners design”<br />

The seamless phase II/III design is one of the most famous adaptive<br />

designs, also called “drop the losers or pick the winners design”.<br />

This design addresses the early (phase II) and confirmatory (Phase<br />

III) objectives, which are traditionally investigated in separated trials,<br />

in one trial. As shown in figure 2, during the first interim analysis, the<br />

Group C (the “loser”) is not judged effective enough (according to a<br />

previous efficacy threshold clearly defined in the protocol). Similarly,<br />

Group A (the “loser”) is dropped during the second interim analysis.<br />

This leads to a final phase with only two groups, the Group B (the<br />

“winner”) and placebo. All the patients included in Group B during<br />

the entire trial are included in the final data analysis for efficacy<br />

assessment. The advantage of this adaptive design is that there is<br />

no stop between the two phases, and doses are selected or stopped<br />

during all the trial according to interim results.<br />

The seamless design is a popular adaptive design because it allows<br />

testing of a larger number of doses with a smaller number of patients<br />

at the beginning of the trial. In the middle of the trial, more patients<br />

can be allocated to the more superior dose because the inferior<br />

ones were stopped before the end of the trial. This design is usually<br />

approved by the authorities for important and innovative therapeutic<br />

treatments. It should be noted that at the end of the first stage,<br />

meaning the first interim analyses, the lack of statistical power may<br />

increase the risk of concluding inefficiency of test products. Indeed,<br />

the efficacy threshold needs to be prospectively planned and it can<br />

be difficult to define it at the time of the protocol development. There<br />

is also an extensive logistics requirement as sponsors needs to adapt<br />

quickly the products production, and formulations and galenic forms<br />

tested in the trial need to be the definitive ones. Finally, because the<br />

primary outcome has to be assessed during the interim analyses,<br />

this design is not applicable if the primary outcome can only be<br />

assessed at the later stage of trials.<br />

Group sequential design<br />

The group sequential design allows for prematurely stopping a trial<br />

due to safety, efficacy (if the treatment is very promising) or futility<br />

(if the treatment is not efficient) with the options of additional types<br />

of adaptations (as seen above) based on interim results. This design<br />

is advantageous in that it can help reduce cost and time as well as<br />

minimize the risk of study participants if the test product appears<br />

unsafe. However, it can be challenging to pre-define the safety, efficacy,<br />

and futility limits for prematurely stopping the trial.<br />

Sample size readjustment<br />

Usually, the sample size is prospectively determined using a targeted<br />

treatment effect size, an assumption about the variability of the<br />

primary endpoint, the desired Type I error rate, and the statistical<br />

power. Inaccurate estimates of the parameters lead to an underpowered<br />

or overpowered study, both of which have negative consequences.<br />

Sample size re-estimation designs allow the parameter<br />

estimates to be updated during an ongoing trial, which can then be<br />

used to adjust the sample size. In theory, the sample size re-estimation<br />

can lead to an increase or a decrease in sample size, though in<br />

practice this is done only to increase the sample size. One reason<br />

is that trials often have other objectives in addition to their primary<br />

objective, including safety objectives for which there is a need of<br />

a certain amount of exposure data. Another reason is for practical<br />

consideration when the recruitment can be completed by the time of<br />

sample size re-estimation, particularly when the primary endpoint is<br />

disease outcomes and observed late in trials. Finally, the potential to<br />

decrease the sample size is best achieved through a group sequential<br />

design with an opportunity to decrease the study sample size by<br />

early termination at the time of the interim analysis.<br />

Blinded methods for sample size adjustment should generally be<br />

considered for most studies. They are based on nuisance parameters<br />

such as variance. Examining the data in this blinded analysis<br />

does not introduce statistical bias, thereby no statistical adjustments<br />

are required. In contrast, sample size adjustment based on knowledge<br />

of the unblinded treatment-effect sizes at an interim stage of<br />

the study can cause an increase in the Type I error rate that can<br />

increase risk of a false positive conclusion. To protect against such<br />

an increase, a statistical adjustment of theType I error rate is necessary<br />

for the final study analysis.<br />

What is your opinion about conducting adaptive design?<br />

Do you think it’s a real opportunity for industry?<br />

Adaptive designs have become popular due to the promise of<br />

greater flexibility and efficiency. When adaptive designs are used<br />

properly, advantages include a smaller sample size, a more efficient<br />

treatment development process (seamless or enrichment designs),<br />

30 No. 3 November/December <strong>2020</strong>

and an increased likelihood of correctly<br />

answering the clinical question of<br />

interest. Thus, it is a real opportunity for<br />

industry to save time and money. Additionally,<br />

a key benefit of adaptive designs<br />

is the ability to reduce the number of<br />

patients exposed to unnecessary risk<br />

with an inefficient treatment. However,<br />

there are some constraints, depending<br />

on the type of adaptive designs, such as<br />

the possible need of independent DMC,<br />

the increase of products logistic, and<br />

statistical concerns.<br />

Are there some regulatory challenges?<br />

Are the authorities supportive of this<br />

kind of design?<br />

While some ethics committees can<br />

be reluctant to authorize some adaptive<br />

designs, such as seamless designs<br />

with a lack of feedback between<br />

phases, regulatory agencies as the FDA<br />

or the European Medicines Agency<br />

(EMA) are promoting the use of adaptive<br />

designs. As an example, among<br />

the 142 studies reviewed by Bothwell<br />

et al., 9 % and 12 % were used for FDA<br />

and EMA product approval considerations,<br />

respectively. Additionally, adaptive<br />

designs are accepted by the European<br />

Food Safety Authority (EFSA) for health<br />

claims submission. If the design is built<br />

with strong scientific justifications and<br />

sound ethical practices and is technically<br />

feasible, there is no reason for the project<br />

to be rejected.<br />

Conclusion<br />

The use of adaptive design is still limited<br />

even in pharma/drug studies. Regulatory<br />

agencies are familiar with adaptive<br />

designs but it is still used by only a<br />

few sponsors. At first, as it was new, it<br />

was used more for innovative treatments<br />

which had to be developed very quickly<br />

because no solution was available for the<br />

patient. So, it was more used for heavy<br />

therapeutics. Now, it is becoming more<br />

and more popular so we can reasonably<br />

think that it will also be considered in the<br />

field of nutrition and food!<br />

References<br />

Guidance for Industry published by the FDA in November 2019 (Adaptive Design Clinical Trials for Drugs and<br />

Biologics).<br />

Several publications that can help with recommendations for reporting, or systematic reviews with examples:<br />

Adaptive Designs in Clinical Trials: Why Use Them, and How to Run and Report Them. BMC Med. 2018 Feb 28;16(1):29.<br />

doi: 10.1186/s12916-018-1017-7<br />

Bothwell LE, Avorn J, Khan NF, et alAdaptive design clinical trials: a review of the literature and ClinicalTrials.govBMJ<br />

Open 2018;8:e018320. doi: 10.1136/bmjopen-2017-018320.<br />

Cerqueira, F. P., Jesus, A. M. C., & Cotrim, M. D. (2019). Adaptive Design: A Review of the Technical, Statistical, and<br />

Regulatory Aspects of Implementation in a Clinical Trial. Therapeutic Innovation & Regulatory Science. https://doi.<br />

org/10.1177/2168479019831240<br />

Flight L, Arshad F, Barnsley R, et al. A Review of Clinical Trials With an Adaptive Design and Health Economic<br />

Analysis. Value Health. 2019;22(4):391-398. doi:10.1016/j.jval.2018.11.008<br />

For more information, please contact<br />

Biofortis Mérieux NutriSciences - Europe<br />

3, route de la Chatterie<br />

44800 Saint Herblain, France<br />

Phone +33 (0)2 40 20 57 99<br />

biofortis-contact@mxns.com<br />

biofortis.merieuxnutrisciences.com<br />

Biofortis Research – US<br />

800-A South Rohlwing Road<br />

Addison, IL 60101<br />

Phone (630) 617-2000<br />

biofortisresearch@mxns.com<br />

www.biofortisresearch.com<br />

No. 3 November/December <strong>2020</strong>

Fortified dairy alternatives<br />

Mineral fortification in dairy alternatives<br />

Dr. Sabrina Fischer and Miriam Feja<br />

Introduction<br />

Dairy products are considered healthy because they provide the<br />

body with minerals and vitamins. Fermented milk products such as<br />

yoghurt are excellent sources of protein, calcium, phosphorus, riboflavin,<br />

thiamine, vitamin B12, folate, niacin, magnesium and zinc.<br />

They also have a positive image because the probiotics they contain<br />

have a beneficial effect on the immune system, as demonstrated by<br />

various studies. 1<br />

Nevertheless, an increasing number of people cannot or do not<br />

want to consume milk products. The reasons range from ecological<br />

and animal welfare concerns, to health aspects such as cow’s milk<br />

allergies, lactose intolerance, concerns around calorie intake and<br />

preventing high cholesterol. 2,3 Plant-based alternatives are therefore<br />

becoming increasingly important, and producers are facing the challenge<br />

of developing products that are as close as possible to cow’s<br />

milk in terms of taste, appearance, stability and nutritional value.<br />

Plant-based milk alternatives<br />

and yoghurts<br />

Plant-based milk alternatives are liquids that<br />

consist of plant proteins homogenised in<br />

water, often together with emulsifiers, stabilisers,<br />

oil, sugar, salt and flavours to imitate<br />

the appearance and consistency of cow’s<br />

milk. 2 Soy is still the most commonly used<br />

source of protein for plant-based drinks and<br />

yoghurts, followed by coconut, almonds and<br />

oats. In recent years, a large number of new<br />

plant-based sources of protein have entered<br />

the market, such as nuts (cashews, hazelnuts<br />

and walnuts), rice, peas, lupine and hemp.<br />

These sources of protein differ widely in terms<br />

of nutritional value, mineral profile and amino<br />

acid profile – as well as in terms of taste.<br />

32 No. 3 November/December <strong>2020</strong>

Fortified dairy alternatives<br />

Indeed, some plant-based raw materials<br />

give rise to unpleasant taste profiles (e. g.<br />

bitter, green or beany notes), and therefore<br />

present a major challenge for manufacturers<br />

looking to produce a pleasanttasting<br />

product. Plant-based yoghurts can<br />

be produced in the same way as traditional<br />

yoghurts, employing fermentation with lactic<br />

acid-producing bacteria such as Bifidobacterium<br />

and Lactobacillus. 3 It may also be<br />

necessary to add sugars for the fermentation<br />

process, depending on the raw material<br />

used. The advantage of this process is<br />

that non-dairy yoghurts also contain living<br />

cultures. However, they still lack the vitamins<br />

and the minerals, especially calcium, found<br />

in cow’s milk-based products. 4<br />

Mineral fortification and<br />

health claims<br />

While calcium enrichment of soy drink has<br />

become relatively common, enrichment<br />

with other minerals and vitamins is still rare.<br />

Added minerals in plant-based yoghurts<br />

are also uncommon, even though fortification<br />

offers an additional opportunity for<br />

promoting health benefits. Minerals such as<br />

calcium, magnesium, potassium and zinc in<br />

particular allow many health claims besides<br />

bone health, addressing topics such as<br />

immunity, muscle function or energy (in line<br />

with the rules on health claims under Regulation<br />

(EC) No 1924/2006).<br />

Table 1: Overview of common mineral salts approved for fortification in Europe. 5<br />

Organic salts are marked in bold, and salts offered by Jungbunzlauer are marked in blue.<br />

that organic mineral salts have higher bioavailability than inorganic<br />

ones. 6–8 Jungbunzlauer offers a wide range of organic mineral salts<br />

in different granulation grades. These are suitable for fortification of<br />

various food matrices and are well established in the dairy industry.<br />

Calcium is important for healthy bones<br />

Calcium is one of the most important modifiable dietary factors for<br />

normal bone development and maintaining bone mass in old age.<br />

About 99 % of the calcium contained in the human body is stored<br />

in the bones in the form of calcium hydroxyapatite. The amount of<br />

calcium present influences peak bone mass. 9 Multiple studies have<br />

shown that insufficient calcium intake is associated with an increased<br />

risk of osteoporosis and related fractures. 9–11 As well as calcium,<br />

other minerals such as magnesium, zinc and vitamin D are crucial<br />

for healthy bones. 6 However, there are still many people whose<br />

calcium intake is inadequate. The USDA Advisory Committee’s <strong>2020</strong><br />

scientific report states that 44 % of Americans are at risk of calcium<br />

inadequacy. 12<br />

Solubility and bioavailability of<br />

different mineral salts<br />

The addition of minerals to complex food<br />

matrices is often challenging and the right<br />

choice of mineral salts is crucial to success.<br />

Mineral salts can be broadly divided into<br />

soluble and insoluble salts. Whereas soluble<br />

salts have an influence on pH and taste,<br />

insoluble salts can lead to a sandy mouthfeel<br />

and sedimentation.<br />

Mineral salts can also be divided into organic<br />

and inorganic salts. Organic mineral salts are<br />

salts of naturally occurring acids, such as<br />

citric acid or lactic acid. They usually have<br />

a more neutral taste than inorganic mineral<br />

salts. In addition, various studies indicate<br />

No. 3 November/December <strong>2020</strong><br />


Fortified dairy alternatives<br />

Dairy products are the most important source of calcium in our diet<br />

and provide 52–65 % of daily calcium requirements. 10,13 Milk contains<br />

120 mg calcium per 100 ml, whereas most plant-based alternatives<br />

contain significantly less. Soy drinks, for instance, contains only<br />

25 mg calcium per 100 ml and coconut drink contains 0 mg per<br />

100 ml. 14,15 Other minerals, such as magnesium and zinc, are only<br />

present in small quantities in many dairy alternatives. People who<br />

do not consume milk-based products typically have a lower intake<br />

of these minerals and are therefore at a higher risk of inadequacy. 11<br />

Enrichment of milk alternatives can therefore make an important<br />

contribution to a healthy diet.<br />

Challenges in the production of fortified dairy alternatives<br />

When enriching milk alternatives, it’s very important to consider the<br />

various properties of the mineral salts in question. Soluble calcium<br />

salts in particular, such as calcium lactate or calcium chloride, can<br />

lead to interactions with proteins due to the high concentration of<br />

free calcium ions. This can affect the pH value and stability of the<br />

product when it is heat treated. Insoluble inorganic salts such as<br />

calcium carbonate or calcium phosphate do not have this problem,<br />

but can precipitate or cause a sandy mouthfeel. Tricalcium citrate is<br />

a good compromise. It has a solubility of approx. 1 g/l and exhibits<br />

inverse solubility: solubility decreases as temperature increases, so<br />

only a very low concentration of free calcium ions is present during<br />

the heat treatment process. 16 Jungbunzlauer offers tricalcium citrate<br />

in a micronised grade (M1098: min. 98 % < 10 μm). Due to the very<br />

fine particle size, sedimentation is less pronounced and the product<br />

offers a pleasant mouthfeel, since the particles are too small to be<br />

detected on the tongue.<br />

Magnesium salts are less common in fortifying dairy alternatives.<br />

During processing, their behaviour is similar to that of calcium salts,<br />

but less mineral salt is required because the recommended daily<br />

intake for magnesium is lower than for calcium. 5 As a result, magnesium<br />

salts have less severe negative impacts on the product than<br />

calcium salts. Among the neutral-tasting magnesium salts, trimagnesium<br />

citrate offers the highest mineral content, but the insoluble<br />

inorganic salt magnesium phosphate has been used more often<br />

because of its neutral taste and low price. However, consumers are<br />

becoming increasingly sceptical about phosphate-containing ingredients.<br />

Various studies have indicated that excessive consumption of<br />

phosphates from food additives can be associated with health risks.<br />

The EFSA therefore called for an upper limit on phosphate levels in a<br />

new risk assessment in 2019. 17<br />

Fortifying with minerals, masking unpleasant flavours<br />

Unpleasant off-tastes can be a problem, especially with plant-based<br />

products: plant proteins can have a beany, green or bitter taste,<br />

making the product less attractive for the consumer.<br />

Previous trials have shown that mineral salts of organic acids – such<br />

as citrate or gluconate salts of magnesium, sodium or potassium –<br />

can mask bitterness and other unpleasant flavours. 18 Fortification<br />

with mineral salts can therefore improve not only the mineral content<br />

but also the taste of milk alternatives. The effect of each mineral salt<br />

on the flavour can vary depending on the matrix and the source of<br />

plant protein used: the mineral salt with the largest impact on offnotes<br />

in the flavour of one product may have much less effect in<br />

another.<br />

Before examining the taste-masking properties of mineral salts, it is<br />

essential to identify the dominant taste characteristics of the various<br />

plant materials. To cover as wide a range of off-notes as possible, a<br />

soy drink and a walnut drink were selected as basis drinks to which<br />

mineral salts were added.<br />

Screening for off-notes<br />

The first step involved a benchmark soy drink (consisting of only water<br />

and 9 % soy) and a self-prepared walnut drink (5 % nut content; for<br />

recipe see table 2) being screened by an internal sensory panel.<br />

These screenings were carried out in form of a CATA (‘check all that<br />

apply’) test. CATA is a rapid descriptive method in which the panellists<br />

are given a list of attributes and are asked to determine which attributes,<br />

as perceived by the panellists, are most relevant to the samples.<br />

Quantitative results were then produced by counting the frequency<br />

of each attribute for each sample. The aim of these sessions was to<br />

find the most relevant attribute for subsequent discrimination tests.<br />

The panellists identified the beany notes in the soy drink and the<br />

bitter notes in the walnut drink as the most dominant off-notes.<br />

Following these screenings, paired comparison tests were carried out<br />

to analyse the soy drink and the walnut drink, focusing on the two<br />

attributes identified by the panellists. As well as the paired comparison<br />

test, the panellists were asked to identify their preference and to<br />

comment on their impression of the taste. This additional information<br />

did not form part of a representative consumer test.<br />

34 No. 3 November/December <strong>2020</strong>

Fortified dairy alternatives<br />

Minerals for masking unpleasant flavours<br />

in milk alternatives<br />

Experimental setup<br />

For each comparison test of the soy drink, the panellists were given<br />

a plain soy drink sample and a sample containing 0.15% added<br />

mineral salt (sodium gluconate, trimagnesium citrate, tripotassium<br />

citrate, calcium lactate gluconate or potassium lactate). The panellists<br />

were asked to identify which sample they perceived as more<br />

beany.<br />

The same test setup was also used to evaluate the taste-masking<br />

properties of mineral salts in walnut drinks. Here, the panellists were<br />

asked to identify which sample they perceived as more bitter.<br />

The test was carried out as a blind experiment; all samples were<br />

randomised and identified only by three-digit codes. The soy drink<br />

was commercially available and was used both with and without<br />

added mineral salts. The walnut test matrix was prepared and fortified<br />

with one of the mineral salts afterwards.<br />

Table 3: Sensory evaluation of soy drink – comments by panellists<br />

Walnut drink results<br />

The addition of 0.15 % sodium gluconate, trimagnesium citrate,<br />

calcium lactate gluconate and potassium lactate significantly<br />

reduced the bitter off-note of the walnut drink (n = 20, α = 0.05).<br />

The panellists also preferred these samples over the plain walnut<br />

drink.<br />

Table 4: Sensory evaluation of walnut drink – comments by panellists<br />

Conclusion<br />

The sensory tests conducted showed that minerals are not only<br />

valuable for mineral fortification of milk substitutes but may also<br />

be suitable for masking undesired off-tastes. The results also<br />

indicated how crucial the selection of the right mineral salt is for<br />

masking specific off-notes.<br />

Table 2: Recipe for walnut drink<br />

The first step in preparing the walnut drink involved mixing the stabilisers<br />

with a quarter of the required amount of water. Another quarter<br />

of the water was heated to 60° C and mixed with lecithin. Both solutions<br />

were stirred thoroughly for 30 minutes. The walnut paste was<br />

meanwhile soaked at 60° C in the rest of the water.<br />

This mixture was then transferred to a Becomix ® and reheated to<br />

60° C. The lecithin solution was homogenised, and then the lecithin<br />

solution and the stabiliser solution were stirred into the walnut-water<br />

mixture. The resulting mixture was homogenised at 60° C and then<br />

had its pH adjusted to 7.0. Finally, the product was pasteurised.<br />

Soy drink results<br />

The addition of 0.15% sodium gluconate, trimagnesium citrate or<br />

tripotassium citrate significantly reduced the beany off-note in the<br />

soy drink (n = 20, α = 0.05).<br />

The samples containing sodium gluconate and trimagnesium citrate<br />

were preferred over the plain soy drink.<br />

While 0.15 % tripotassium citrate worked well for masking beany<br />

off-notes of the soy drink, calcium lactate gluconate and potassium<br />

lactate worked well for the bitter off-note of the walnut drink.<br />

Sodium gluconate and trimagnesium citrate masked both off-notes.<br />

At a concentration of 0.15 %, trimagnesium citrate fulfils a dual<br />

function: its addition allows the product to be claimed as a source<br />

of magnesium, and it also helps enhance the taste of the product<br />

by masking beany and bitter off-notes.<br />

Mineral fortification in non-dairy yoghurt<br />

As described above, specific minerals can be utilised as taste<br />

masking agents for undesired off-notes in soy and walnut drinks.<br />

While milk alternatives are often fortified so that their mineral<br />

content matches that of cow’s milk, fortification of non-dairy yoghurt<br />

can go further. Yoghurt products are generally considered healthy<br />

and their set portion size allows them to be used as an important<br />

source of minerals. Therefore yoghurt fortification can be used to<br />

achieve “high in minerals” status – an especially interesting option<br />

for vegan yoghurts.<br />

However, since non-dairy yoghurts are produced directly from milk<br />

alternatives, additional minerals could have a negative effect on the<br />

stability, texture and taste of plant-based yoghurts. The following trials<br />

No. 3 November/December <strong>2020</strong><br />


Fortified dairy alternatives<br />

therefore focused on the influence of minerals on taste and texture in<br />

a plant-based yoghurt matrix. Unlike the trials with non dairy drinks<br />

not only one mineral was added, these used a combination of trimagnesium<br />

citrate and tricalcium citrate at concentrations that allow a<br />

“high mineral content” claim. Because soy is still the most common<br />

basis for non-dairy yoghurt, the following trials were carried out using<br />

a soy-based matrix.<br />

The US Food and Drug Administration (FDA) gives a daily recommended<br />

intake of 1300 mg calcium and 420 mg magnesium per<br />

day. A product can be labelled as “high in calcium/magnesium” if it<br />

provides a minimum of 20 % of the daily value (DV) (FDA 21CFR).<br />

The reference amount customarily consumed (RACC) is set at 150 g<br />

per portion, as this is a typical amount for commercially available<br />

single-portion yoghurts.<br />

In the EU, Regulation (EU) No 1169/2011 requires that 100 g of final<br />

product contains 30 % of the Nutrient Reference Value (NRV) if the<br />

product is to be labelled as “high in calcium/magnesium”. The NRV<br />

is set at 800 mg calcium and 375 mg magnesium per day.<br />

Table 6: Recipe for soy yoghurt<br />

To produce the test yoghurts, a soy drink (protein content approx.<br />

5–7 g per 100 g) was added to 0.1% pectin and heated to 90° C<br />

for 5 minutes in a Thermomix ® . Trimagnesium citrate and tricalcium<br />

citrate were then stirred in until evenly suspended. After cooling the<br />

mixtures to below 40° C, the yoghurts were inoculated with lactic<br />

acid bacteria. The yoghurts were then poured into sealable cups and<br />

placed in a warming chamber at 40° C until a final pH of 4.7 was<br />

achieved.<br />

Table 5: Overview of requirements for “high in calcium/magnesium”<br />

claims in EU and USA<br />

In the experimental setup, the quantities for a “high in calcium/<br />

magnesium” claim under US regulations were used. Besides visually<br />

analysing stability, the internal sensory panel also tested the influence<br />

of the added minerals on the flavour of the product.<br />

Experimental setup<br />

Apart from the raw materials and the use of starter cultures for dairy<br />

alternatives, dairy and non-dairy yoghurt are processed in exactly the<br />

same way.<br />

Table 7: Nutritional values of the test yoghurt (values are per 150 g yoghurt)<br />

Sensory evaluation of mineral-fortified soy yoghurt<br />

Triangle tests (α = 0.05) were used to find out if the addition of large<br />

quantities of tricalcium citrate and trimagnesium citrate influences<br />

the overall taste of a fortified product compared to the non-fortified<br />

product.<br />

In a triangle test, panellists are given three samples, two of which are<br />

identical, and are asked to identify the third, non-identical sample. A<br />

significant difference between this sample and the other two samples<br />

would show that mineral fortification affects the flavour of the product.<br />

The panellists were also asked to comment on their decision and to<br />

choose their preferred yoghurt for each test set.<br />

The test was carried out as a blind experiment; all samples were<br />

presented in a randomised order and identified only by threedigit<br />

codes.<br />

36 No. 3 November/December <strong>2020</strong>

Fortified dairy alternatives<br />

Sensory results and conclusion<br />

The sensory panel (n = 18) could not detect<br />

any difference between the fortified and the<br />

unfortified versions of the soy yoghurt.<br />

It can therefore be concluded that the addition<br />

of mineral salts has no impact on the<br />

taste, texture, stability or appearance of the<br />

product.<br />

The results demonstrate that a fortification<br />

with trimagnesium citrate and tricalcium<br />

citrate has no detectable effect on taste or<br />

texture for the consumer, even if large quantities<br />

of these minerals are used.<br />

avoid this, it is crucial that soluble mineral<br />

salts are added after the heating step. Since<br />

heat treatment is carried out to sterilise the<br />

product, the mineral salts must be added<br />

using a sterile method. There are various<br />

options:<br />

– Mixing the minerals with water to produce<br />

a slurry or solution, followed by heat treatment<br />

before adding the minerals to the<br />

drink or yoghurt<br />

– Adding the mineral salt solution using<br />

sterile filtration<br />

– Adding the mineral salts to the fruit preparation,<br />

then sterilising this preparation<br />

before adding it to the yoghurt<br />

Insoluble mineral salts present a lower risk<br />

of affecting product stability, so they can<br />

usually be added in micronised powder form<br />

before the heating step. Soluble mineral salts<br />

with low or moderate solubility can only be<br />

Cleaner label – replacing calcium<br />

phosphate<br />

As mentioned above, mineral salts of phosphates<br />

are still commonly used, even though<br />

EFSA has issued new advice on phosphates.<br />

17<br />

Bioactive Collagen Peptides ® stimulate<br />

the body’s own collagen metabolism<br />

To further investigate whether phosphates<br />

could be replaced with clean label ingredients<br />

in non-dairy yoghurt, another soy<br />

yoghurt test was conducted. A soy yoghurt<br />

fortified with calcium phosphate was<br />

compared to a version fortified with tricalcium<br />

citrate in a triangle test.<br />

Again, the panellists (n = 12) could not detect<br />

any difference between the two versions.<br />

This indicates that cleaner labelling by<br />

switching from phosphates to label-friendly<br />

citrates can easily be achieved without any<br />

negative impact on the taste, texture, colour<br />

or appearance of the final product.<br />

Body Toning<br />

• Increases lean mass and<br />

decreases fat mass<br />

Bone Health<br />

• Increases bone<br />

mineral density<br />

Osteoporosis<br />

Normal bone<br />

matrix<br />

Beauty from Within<br />

• Increases skin elasticity<br />

and reduces depth<br />

of wrinkles<br />

Connective Tissue<br />

Improvement<br />

• Strengthens ligaments<br />

and tendons<br />

Both of these mineral salts have very low<br />

solubility and comparable reactivity. This<br />

means that citrates could be integrated into<br />

the production of non-dairy yoghurt without<br />

any change to the production process.<br />

Joint Health<br />

• Recovers joint cartilage<br />

and reduces joint pain<br />

Incorporating mineral salts into the<br />

production process<br />

As mentioned above, products containing<br />

dissolved cations such as calcium tend<br />

to be unstable during heat treatment. To<br />

GELITA AG · Uferstr. 7 · 69412 Eberbach · Germany · www.gelita.com

Fortified dairy alternatives<br />

instead of a soy-based one to find out whether stability can be maintained<br />

if a different plant protein is used. Provided that the yoghurt is<br />

processed as recommended, it was found that these versions did not<br />

demonstrate a lack of stability. However, the recommendations for<br />

the processing step must be followed meticulously.<br />

Conclusion<br />

The experiments described above show that mineral salts can be<br />

added to milk alternatives without any negative impact on texture or<br />

stability, and that this process can even be exploited to mask various<br />

undesired plant off-notes. Different plants proteins create varied<br />

undesired flavours, so selecting the right mineral salt plays an essential<br />

role in successfully masking such off-notes.<br />

Some mineral salts (e.g. trimagnesium citrate) can even fulfil a dual<br />

function, enhancing flavours on the one hand and helping achieve<br />

fortification claims on the other.<br />

added in small quantities before heat treatment. The levels generally<br />

depend on the type of milk alternative in question, as the different<br />

plant proteins vary in their sensitivity to applied stress in form of heat,<br />

pH changes or shear forces.<br />

Adding tricalcium citrate and trimagnesium citrate after the heating<br />

step to produce a high-magnesium/high-calcium soy yoghurt (in<br />

line with FDA standards) did not have any negative impact on the<br />

yoghurt’s texture, stability or appearance.<br />

The level of magnesium and calcium fortification required for a “high<br />

in calcium/magnesium” claim is higher under the EU standards than<br />

the US standards. Therefore, a test was also carried out to find out<br />

whether the stability and texture of non-dairy yoghurt can be maintained<br />

if even higher levels of mineral salts are added after the heating<br />

stage. Again, this experiment produced soy yoghurt with normal<br />

yoghurt-like stability and texture, demonstrating that high amounts of<br />

minerals can be incorporated into the yoghurt matrix after the heating<br />

step without any detectable loss of stability or texture.<br />

Nowadays, various types of plant proteins are on the rise. Peas are<br />

a particularly common new ingredient for non-dairy yoghurts. The<br />

trials were therefore repeated using a pea-based yoghurt matrix<br />

For more information, please contact<br />

Dr. Sabrina Fischer – Junior Product Manager<br />

sabrina.fischer@jungbunzlauer.com<br />

Miriam Feja – Application Technology Assistant<br />

miriam.feja@jungbunzlauer.com<br />

Jungbunzlauer Ladenburg GmbH<br />

www.jungbunzlauer.com<br />

Regarding non-dairy yoghurt and its complex texture, the experiments<br />

with soy yoghurt showed that mineral salts can be successfully<br />

added – even in large quantities – without having to compromise<br />

on taste, texture or stability of the final product.<br />

References<br />

[1] Hashemi Gahruie, H.; Eskandari, M. H.; Mesbahi, G. & Hanifpour, M. A. Scientific and<br />

technical aspects of yogurt fortification: A review. Food Sci. Hum. <strong>Wellness</strong> 4, 1–8 (2015).<br />

[2] Sethi, S.; Tyagi, S. K. & Anurag, R. K. Plant-based milk alternatives an emerging<br />

segment of functional beverages: a review. J. Food Sci. Technol. 53, 3408–3423 (2016).<br />

[3] Ranadheera, C. S.; Vidanarachchi, J. K.; Rocha, R. S.; Cruz, A. G. & Ajlouni, S. Probiotic<br />

delivery through fermentation: Dairy vs. non-dairy beverages. Fermentation 3, 1–17 (2017).<br />

[4] Chalupa-Krebzdak, S.; Long, C. J. & Bohrer, B. M. Nutrient density and nutritional value<br />

of milk and plant-based milk alternatives. Int. Dairy J. 87, 84–92 (2018).<br />

[5] Gerhart, M. & Schottenheimer, M. Mineral fortification in dairy. <strong>Wellness</strong> <strong>Foods</strong> Eur.<br />

(2013).<br />

[6] Domke, A.; Großklaus, R.; Niemann, B.; Przyrembel, H. & Richter, K. Verwendung von<br />

Mineralstoffen in Lebensmitteln. Bundesinstitut für Risikobewertung (2004).<br />

[7] Harvey, J. A. et al. Superior Calcium Absorption from Calcium Citrate than Calcium<br />

Carbonate Using External Forearm Counting. J. Am. Coll. Nutr. 9, 583–587 (1990).<br />

[8] Kappeler, D. et al. Higher bioavailability of magnesium citrate as compared to magnesium<br />

oxide shown by evaluation of urinary excretion and serum levels after single-dose<br />

administration in a randomized cross over study. BMC Nutr. 3, 1–12 (2017).<br />

[9] Zhu, K. & Prince, R. L. Calcium and bone. Clin. Biochem. 45, 936–942 (2012).<br />

[10] Włodarek, D. et al. Calcium intake and osteoporosis: The influence of calcium intake<br />

from dairy products on hip bone mineral density and fracture incidence – A populationbased<br />

study in women over 55 years of age. Public Health Nutr. 17, 383–389 (2014).<br />

[11] Schumann, L.; Martin, H.-H. & Keller, M. Calcium, Milch und Knochengesundheit.<br />

Behauptungen und Fakten. Ernährung im Fokus 14, 326–331 (2014).<br />

[12] USDA Advisory Committee. Scientific Report of the <strong>2020</strong> Dietary Guidelines Advisory<br />

Committee. (<strong>2020</strong>).<br />

[13] Rene, R. Dairy products, yogurts, and bone health. Am. J. Clin. Nutr. 99, 1256S–1262S<br />

(2014).<br />

[14] U.S. DEPARTMENT OF AGRICULTURE. Soy milk. FoodData Central https://fdc.nal.usda.<br />

gov/fdc-app.html#/food-details/781114/nutrients, accessed on 6th August <strong>2020</strong>.<br />

[15] U.S. DEPARTMENT OF AGRICULTURE. Coconut milk. FoodData Central https://fdc.nal.<br />

usda.gov/fdc-app.html#/food-details/572117/nutrients, accessed on 6th August <strong>2020</strong>.<br />

[16] Gerstner, G. Dairy products: the calcium challenge. Int. Food Ingredients 3, 45–48<br />

(2002).<br />

[17] Younes, M. et al. Re-evaluation of phosphoric acid-phosphates – di-, tri- and polyphosphates<br />

(E 338–341, E 343, E 450–452) as food additives and the safety of proposed extension<br />

of use. EFSA J. 17, 5674 (2019).<br />

[18] Besler, L. & Gerstner, G. Formulating better tasting infant formula. Jungbunzlauer Fact<br />

Sheet (2015).15<br />

38 No. 3 November/December <strong>2020</strong>

Dairy products<br />

Photo ® : Fotolia/emuck<br />

Yogurt Powders: the health benefits of yogurt<br />

with added convenience<br />

Harmony Villemin, on behalf of Epi Ingredients<br />

According to the Codex Alimentarius,<br />

yogurt is a fermented milk characterized<br />

by the use of specific starter<br />

cultures for fermentation, symbiotic<br />

cultures of Streptococcus thermophilus<br />

and Lactobacillus delbrueckii subsp.<br />

Bulgaricus, which shall be viable,<br />

active and abundant ( >10 7 CFU/g ) in<br />

the product throughout its shelf life;<br />

unless the product is heat treated after<br />

fermentation in which case some of<br />

these requirements do not apply.<br />

Although yogurt-making now relies on<br />

standard starter cultures to provide a<br />

consistent product, ensure quality and safety<br />

and meet consumer expectations, it was not<br />

always the case. Evidence of the consumption<br />

of fermented milk dates to ancient times<br />

when fermentation was the result of the spontaneous<br />

activity of native bacteria in milk and<br />

primarily used to preserve it. As such, yogurt<br />

has been a significant part of the human diet<br />

for centuries in many cultures. Not only was<br />

it used to extend milk’s shelf life, but its nutritional<br />

benefits were also recognized early<br />

on and it was consumed for its medicinal<br />

proper ties as early as the Middle Ages to heal<br />

conditions such as diarrhea or burnt skin.<br />

Nowadays, yogurt’s perceived health benefits<br />

are still a major driving force behind<br />

its consumption as increasingly healthconscious<br />

consumers seek simple natural<br />

solutions to support their pursuit of a healthy<br />

lifestyle. Beyond the appeal of its distinctive<br />

tangy flavor, a lot of consumers are attracted<br />

to yogurt for its alleged positive effects on<br />

digestive health, which most people now<br />

understand is the foundation for overall<br />

wellness. Yogurt has indeed become a true<br />

health food staple. It is indeed packed with<br />

the nutrients from milk, such as high quality<br />

protein, calcium, and other valuable vitamins<br />

and minerals, and also contains additional<br />

beneficial compounds resulting from<br />

the microbiota’s metabolic activity, not to<br />

mention the live cultures themselves and<br />

their own positive impact on human health.”<br />

Beneficial health effects of yogurt<br />

Although yogurt and other fermented dairy<br />

products have been consumed for millennia<br />

and often associated with good health and<br />

longevity, it is not until more recently that<br />

scientists began to explore their potential<br />

health benefits. “The lactic acid bacteria<br />

present in fermented milk are suggested to<br />

confer beneficial effects on human health<br />

through the modulation of the intestinal<br />

microbiota, which affects the host either<br />

directly or indirectly.” 1<br />

Yoghurt cultures promote better lactose<br />

digestion<br />

One of the most studied benefit of yogurt<br />

pertains to its role in lactose digestion and<br />

relates to products containing live cultures<br />

of Lactobacillus delbrueckii, Lactobacillus<br />

bulgaricus and Lactobacillus Streptococcus.<br />

The European Food Safety Authority<br />

(EFSA) has even approved the following<br />

generic claim: “yoghurt helps to promote<br />

No. 3 November/December <strong>2020</strong><br />


Dairy products<br />

lactose digestion”. A yogurt must contain at least 10 8 CFU/serving<br />

(100 ml minimum) in order to qualify for the use of this health<br />

claim. After reviewing the findings from a number of human trials,<br />

EFSA’s Panel on Nutrition, Novel <strong>Foods</strong> and Food Allergens (NDA)<br />

concluded that improved lactose digestion had a beneficial effect on<br />

individuals with lactose maldigestion.<br />

According to the National Institute of Diabetes and Digestive and<br />

Kidney Diseases, experts have estimated the global prevalence of<br />

lactose malabsorption to affect about 68 % of the global population.<br />

Although asymptomatic in most cases, lactase deficiency can lead<br />

to lactose intolerance which can affect a person’s health and quality<br />

of life by preventing them from getting enough nutrients such as the<br />

calcium or vitamin D present in milk products which contain lactose,<br />

and by causing gastrointestinal troubles such as bloating, gas, diarrhea<br />

and abdominal pain. In such cases, it is however not recommended<br />

to reduce consumption of dairy products as it could lead<br />

to deficiencies in essential nutrients. Instead it is recommended that<br />

lactose intolerant people shift their habits to reduce their consumption<br />

of milk and opt for yogurt and aged cheeses instead. Yogurt is<br />

indeed a great alternative as its lactose content is naturally lower than<br />

that of milk and, even though it still contains significant amounts, the<br />

lactase enzyme produced by yogurt cultures helps people it break<br />

down, thus improving lactose digestion and reducing the discomfort<br />

usually associated with its consumption in lactose intolerant people.<br />

Lactose intolerant people are, however, not the only ones to benefit<br />

from yogurt and associated probiotic bacteria’s consumption.<br />

Yogurt to prevent and cure acute diarrhea in children 2<br />

According to CERIN, the consumption of probiotics, including yogurt<br />

cultures, are an effective way to reduce the risk of acute diarrhea<br />

in children by 57 % on average. It has also<br />

proven to reduce the severity and duration<br />

of diarrhea in children by as much as a day.<br />

Containing about 90 % water, yogurt is great<br />

to keep children hydrated, which is a priority<br />

during acute diarrhea episodes. In developing<br />

countries, the World Health Organization<br />

(WHO) even recommends yogurt to<br />

support children with persistent diarrhea.<br />

Yogurt cultures help regulate the gut<br />

microbiome<br />

The positive effects of consuming yogurt<br />

regularly are often credited to how it<br />

changes the composition of the microbiome.<br />

Although yogurt cultures are only passing<br />

through and do not normally colonize the<br />

gut, when consumed regularly and in sufficient<br />

quantities, they can have a profound<br />

impact on the composition and function of<br />

the gut microbiota such as improving bowel<br />

function, strengthening the immune system,<br />

etc. For example, studies have shown that<br />

regular consumption of yogurt in seniors<br />

suffering from constipation can significantly<br />

improve bowel movement’s frequency and<br />

stool consistency as well as reduce bloating<br />

and abdominal pain usually associated with<br />

constipation.<br />

Compared to other modalities, yogurt<br />

consumption can be a great way to heal mild<br />

gastrointestinal disorders without the negative<br />

effects that can stem from restrictive<br />

diets or antibiotics therapy. Moreover, yogurt<br />

is much more affordable than some of the<br />

other options available on the market and a<br />

completely natural one.<br />

Yogurts and fermented milks potential in<br />

improving metabolic health<br />

“Recent clinical and epidemiological<br />

studies have provided evidence linking<br />

yogurt consumption with a range of systemic<br />

benefits. These include lower body weight<br />

or less weight gain, smaller waist circumference<br />

and lower body fat, improved cardiometabolic<br />

outcomes, and reduced risk of<br />

type 2 diabetes mellitus.” 1<br />

Photo ® : Adobe Stock/Maksim Slesartschuk<br />

With obesity, cardiovascular diseases and<br />

type 2 diabetes rising at an alarming rate<br />

across the world as a result of unhealthy life-<br />

40 No. 3 November/December <strong>2020</strong>

Dairy products<br />

styles, it is paramount to find effective solutions<br />

that can help thwart this growing trend.<br />

Although more studies are needed to get<br />

a better understanding of the full scope of<br />

the metabolic health benefits provided by<br />

the regular consumption of yogurt as well<br />

as its mechanism of action, research points<br />

to the fact that yogurt and fermented milks<br />

consumption could be associated with a<br />

reduced risk of metabolic diseases and<br />

specifically type 2 diabetes.<br />

Research findings suggests that people<br />

consuming at least one yogurt or serving<br />

of fermented milk daily see their risk of<br />

developing type 2 diabetes reduced by<br />

15–20 % compared to individuals who never<br />

or rarely eat yogurt. A study also found<br />

out that yogurt consumption was linked to<br />

healthier lifestyles with participants who<br />

consumed the most yogurt likely to have a<br />

healthier diet overall and less likely to engage<br />

in unhealthy behaviors such as smoking,<br />

overeating or staying inactive. 3<br />

Yogurt’s possible positive impact on other<br />

health conditions<br />

Skin conditions such as eczema or food allergies<br />

can have devastating effects on people’s<br />

quality of life, but recent studies suggest that<br />

yogurt consumption in infancy could reduce<br />

the infant’s likelihood to later develop these<br />

diseases. 4<br />

Other health benefits that yogurt consumption<br />

is thought to provide include promoting<br />

heart health, strengthening the immune<br />

system, or even helping reduce symptoms<br />

of depression. All of which needs to be<br />

confirmed through additional research.<br />

However, it seems safe to say that, overall,<br />

consuming yogurt regularly can only be<br />

beneficial to our health, in more ways than<br />

we know. Thanks to its impressive versatility,<br />

modern consumers can benefit from the<br />

positive health effects of yogurt through a<br />

variety of products and formats that fit every<br />

eating occasion, every lifestyle, and every<br />

food preference. However, one of the main<br />

challenges with fresh yogurt is preservation<br />

and the need for refrigeration!<br />

Photo ® : Adobe Stock/goodluz<br />

The convenience advantage with Epi Ingredients<br />

yogurt powders<br />

The need for refrigeration of fresh yogurt and fermented products<br />

comes with extra costs, can be difficult to achieve in some regions<br />

of the world and does not always fit well in consumers’ increasingly<br />

busy lifestyles and their ongoing quest for convenient, “on-the-go”<br />

healthy options.<br />

As a global leader in the field of dairy processing, Epi Ingredients<br />

tackled this challenge and is proud to make access to fermented<br />

products more convenient through a range of shelf-stable, dry yogurt<br />

ingredients, some of which containing the same live and active<br />

cultures as the ones found in fresh yogurt. EPILAC, whole range of<br />

premium yogurt powders, is the perfect fit for new developments<br />

carrying the healthful halo of yogurt by delivering the same cultures<br />

and thus the same health benefits as their traditional counterparts<br />

but without the need for refrigeration.<br />

Thanks to the company’s strong technological expertise, they were<br />

able to develop a unique manufacturing process allowing them to dry<br />

blends of milk and live cultures, keeping the cultures alive throughout<br />

the process and into the finished powder, if required.<br />

EPILAC powders are also naturally perfectly adapted to regions where<br />

harsh climate conditions might hinder milk production or pose a challenge<br />

when it comes to preserving fresh milk or refrigerated products.<br />

Whether a company is looking for functionality, nutrition or flavor, Epi<br />

Ingredients’ yogurt powders have it all. The company even has the<br />

capabilities and technological expertise to develop taylor-made yogurt<br />

powders to meet their customers specific requirements, whether it is<br />

a custom strain combination or an exclusive flavor profile. Regulatory<br />

experts are also available to support customers when working on the<br />

wording for their packaging.<br />

No. 3 November/December <strong>2020</strong><br />


Dairy products<br />

EPILAC premium yogurt powders features:<br />

– Smooth flavor with a pleasant yogurt note<br />

– Natural acidity<br />

– Ease-of-use & versatility<br />

– Clean label<br />

– High microbiological quality adapted to dry mixing<br />

In an effort to go one step further to help their customers, Epi<br />

Ingredients vowed to develop, over the years, a series of on-trend<br />

concepts designed to inspire manufacturers while showcasing the<br />

unique characteristics of its ingredients. Their first concept, awardwinning<br />

SoFlexi, was a versatile powdered mix that allows consumers<br />

to create fresh yogurt-tasting snacks at their convenience. Whether<br />

they are in the mood for a drinking yogurt, some ice cream, or an<br />

acid drink, they can indulge almost instantly thanks to SoFlexi! It was<br />

specifically created to demonstrate possible applications of EPILAC<br />

yogurt powders and, how with a shelf stable product, consumers can<br />

still reap all the health benefits associated with Streptococcus thermophilus<br />

and Lactobacillus bulgaricus active flora.<br />

Beyond powders containing live and active cultures, the EPILAC range<br />

also offers powders featuring inactive flora for brands whose focus<br />

is on flavor more than health benefits. The company also recently<br />

developed new ethnic varieties to quench consumers’ thirst for<br />

adventure and discovery through new flavors. “Consumers interest in<br />

ethnic products is multifaceted and not limited to seeking the excitement<br />

of trying food from another culture.” In fact, consumers also<br />

For more information, please contact<br />

Mathieu Lucot,<br />

Marketing Manager<br />

EPI Ingredients & Laïta Nutrition,<br />

French dairy cooperative Laïta<br />

MLUCOT@laita.fr<br />

value the authenticity and simple processing dictated by the traditional<br />

making of these products. Ultimately, they are also driven by a<br />

quest for wellness, attracted by the high protein content of a variety<br />

or the specific probiotic makeup of another that might provide exclusive<br />

health benefits.<br />

In a nutshell<br />

Although consumed for thousand of years, we are only now starting<br />

to understand and embrace the full potential of yogurt and fermented<br />

dairy products in supporting our health; and even though more<br />

research is needed to uncover additional evidence of their positive<br />

effect on human health, we can say without hesitation that making<br />

yogurt and fermented dairy products a part of people’s daily nourishment<br />

could have tremendous positive repercussions on the global<br />

health status of the world’s population. To make it easier for consumers<br />

to include health-promoting bacteria to their diet consistently, Epi<br />

Ingredients has developed a range of premium yogurt powders<br />

containing the same live and active cultures as fresh yogurt, thus<br />

eliminating the need for refrigeration and opening up a world of possibilities<br />

for brands ready to develop innovative yogurt products.<br />

References<br />

1<br />

Sharon M. Donovan and Robert Hutkins. Introduction to the Fifth Global Summit on<br />

the Health Effects of Yogurt. Nutrition Reviews Vol. 76(S1):1-3. 16 November 2018, doi:<br />

10.1093/nutrit/nuy054<br />

2<br />

CERIN. Ferments laitiers et santé. Publié le 26 décembre 2016, mise à jour le 3 février<br />

2017, https://www.cerin.org/etudes/ferments-laitiers-sante/<br />

3<br />

SYNDIFRAIS. Maladies métaboliques : l’intérêt des yaourts et laits fermentés dans les<br />

régimes adaptés. Nutrition et Produits Laitiers Frais – La Lettre Scientifique et Pratique de<br />

SYNDIFRAIS n°8. Juin 2017.<br />

4<br />

Yogurt in Nutrition. Yogurt is associated with reduced risk of eczema and allergy in infancy.<br />

27 January <strong>2020</strong>. https://www.yogurtinnutrition.com/yogurt-is-associated-with-reducedrisk-of-eczema-and-allergy-in-infancy/<br />

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