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Wellness Foods Europe Bioactives
Benegut ® demons trated beneficial
effects to improve gastro intestinal
discomfort in healthy people
Dr Sybille Buchwald-Werner
Gastrointestinal discomfort, e. g. bloating or
rumbling, is a common symptom in other wise
healthy adults. Approximately 20 % of the
population, particularly women, suffer from
gastrointestinal discomfort and thus affects
quality of life. People feel uncomfortable and
have to loosen their clothes. Often a reduced
ability to work and participate in social or
recreational activities is reported. Consumer
research indicates that today one third of
consumers looking for gut health support do
not find an effective product that works for
them. [1] This may be related to the fact that
even people with a healthy gut micro flora
and no food intolerance suffer from digestive
discomfort.
Recent studies discovered a link between
the body and mind, called the brain-gut-axis.
Psychosocial factors, such as e. g. daily stress
may cause altered gut physiology leading to
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Bioactives Wellness Foods Europe
PubID-Alg71,5x217mm.pdf 1 12/04/13 16:14
ileum contractions and consequently gastrointestinal
symptoms. [2]
Vital Solutions identified this interesting
business opportunity and develop a proprietary
Perilla frutescens extract, branded as
Benegut ® , which is ideally suited to improve
gastrointestinal discomfort by interacting
with the neurological system. Benegut ® is
a proprietary Perilla frutescens leaf extract,
which contains a specific ratio of selected
flavonoids, particularly Vicenin 2, in combination
with rosmarinic acid; all active compounds
naturally found in Perilla. Peril la
frutescens (L.) Britton is an annual eatable
herbaceous plant native to Asia. Common
names are Shiso, Japanese Melisse or Japanese
Basil. Perilla belongs to the mint family,
Lamiaceae. The green Perilla leaves are used
as tea, food or spice. In vitro and ex vivo
studies demonstrated that Benegut ® C
combines
prokinetic and antispasmodic as well
M
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as anti-inflammatory effects. [3, 4] A human
nutritional study was consequently the next
research and development step to substantiate
the results.
The aim of the intervention was to
demons trate the effects of the proprietary
N
Perilla extract on gastrointestinal discomfort
in healthy subjects with gastrointestinal discomfort
and reduced bowel movements in
comparison to a placebo product. It is challenging
to show beneficial gut health effects
within the target population of healthy people,
because the intention is to demonstrate
an improvement of a physiological status
which is still defined as healthy but affects
quality of life. In addition it is known that
human studies investigating gastrointestinal
health show a high placebo effect. [5]
The study was performed double blind,
randomized, placebo-controlled and with
parallel design. It consisted of screening, a
two-week run-in phase followed by a fourweek
blinded study product consumption
phase. Prior to trial start, volunteers were
screened for their eligibility to take part in
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May 2013 – Wellness Foods Europe | 19

Wellness Foods Europe Bioactives
the nutritional intervention trial and selected
based on a defined degree of gastrointestinal
discomfort and bowel function. A 2
weeks run-in phase was carried out, without
treatment, to asses baseline conditions for
gastrointestinal (GI) discomfort and bowel
function. Comparable results between
groups and volunteers were found and 41
females and 9 males were included into the
study.
50 healthy people, ages 30–70, were administered
capsules containing 150 mg proprietary
Perilla frutescens leaf extract or Placebo
product twice a day, for four weeks.
The study population represented the distribution
of GI discomfort within the general
population. Particularly women suffer from
GI discomfort and reduced bowel movements
and they are generally more willing
to participate in trials. During the study the
subjects were asked not to consume any
obvious pro- and prebiotic supplements,
food or drinks, and food especially rich in
fibre, or other pro ducts, which may affect
the study results. 14 days prior to and during
the whole study period, volunteers were
not allowed to take any laxatives. All volunteers
were compliant to this demand. As
stress might have a great impact on bowel
function, different facets of stress were assessed
using the perceived stress questionnaire
(PSQ20). During the study period, no
signifi cant changes of tension and demands
were reported. During the run-in and during
the intake period volun teers daily documented
their gastrointestinal discomfort
symptoms. Bloating, passage of gas, feeling
of fullness, GI-rumbling and abdominal discomfort
was daily rated from 0 (not at all)
to 4 (extremely).
Benegut ® improved all investigated symptoms
(bloating, passage of gas, GI-rumbling,
feeling of fullness and abdominal discomfort)
significantly over the four week intake
phase and was particularly effective to reduce
bloating and abdominal discomfort in
women. 80 % of volunteers taking Benegut ®
reported substantial improvement of gastrointestinal
discomfort. See figure 1.
Figure 1: Responder rates in %
Benegut ® was able to improve gastrointestinal
discomfort up to over 40%. See figure 1.
Benegut ® was particularly effective to reduce
bloating and abdominal discomfort in women.
See figure 3.
Figure 2 Improvement rates (%) total study population
Reduction in bloating was already measurable
within the first two weeks of intake and was
even strengthened within the second two
weeks of treatment. 83 % of all volunteers
within the Perilla group showed a reduction
in bloating. Within the Perilla group passage
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Bioactives Wellness Foods Europe
Figure 3: Improvement rates (%) subgroup women
of gas was significantly reduced, with a responder
rate of 67 %. Also this effect was already
measurable within the first two weeks
of intake and was even strengthened within
the second two weeks of treatment. Perilla intake
led to a continuous reduction in rumbling
in the course of the four week intake
phase. Within the Perilla group rumbling was
significantly reduced and the responder rate
was 71 %. Perilla demonstrated also a significantly
reduction in abdominal discomfort
with a responder rate of 71 %.
Study results confirmed in vitro and ex
vivo results, which identified that the mode
of actions of Benegut ® are prokinetic and anti-spasmodic
effects, leading to an immediate,
perceptible relief from GI discomfort.
Responder rates and odds values demonstrated
physiological relevance of Benegut ® for reduction
of GI symptoms and that Benegut ® is
suitable to reduce GI discomfort symptoms
prior to placebo. Benegut ® is particularly effective
to reduce bloating and abdominal discomfort
in women.
The study results are very promising,
taking into consideration the challenging setup
of a nutritional human study with healthy
volunteers and the area of digestive health,
which is known for high placebo effects.
Benegut ® is an unique ingredient, because
it combines prokinetic as well as antispasmodic
and anti-inflammatory efficacy leading
to an immediate relief of gastrointestinal
discomfort and thus contributing to overall
quality of life. Benegut ® is a high quality, sustainable,
natural food ingredient, which is IP
protected and approved to be used in dietary
supplements in Europe and the U.S.
Benegut ® was developed and is marketed
by Vital Solutions. Vital Solutions is an innovative
and fast growing company specialized
in the development and marketing of innovative,
natural ingredients to be used in dietary
supplements, functional foods and foods.
References >
[1] http://www.progressivegrocer.com/products/supplier-news/id994/category-captaindigestive-
health-novartis-consumer-health/
[2] D.A. Drossmann, The functional gastrointestinal
disorder and the Rome III process,
Gastroenterology, 2006
[3] Verspohl, E.J., et al.Testing of Perilla
frutescens extract and Vicenin 2 for their
antispasmodic effect. Phytomedicine, 2013
[4] Buchwald-Werner S., et al, Investigation
of a Perilla frutescens special extract, Anti-inflammatory
and immune-modulatory
proper ties, Agrofood Industry Hi Tech, 2012
[5] Irvine, E. J, et al, Design of Treatment
Trials for Functional Gastrointestinal Disorders,
Gastroenterology, 2006
The Author: Dr Sybille Buchwald-Werner,
Founder and managing director of
Vital Solutions GmbH
Hausinger Str. 6
40764 Langenfeld, Germany
E-Mail: Sybille.Buchwald-Werner@vitalsolutions.biz
www.vitalsolutions.biz
www.benegut.com
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