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Annex 1.7: “Dossier for the Scientific Substantiation of Claims related to PalatinoseTM and its Nutritional Physiological Properties”
CONFIDENTIAL Regulatory Affairs & Nutrition Communication – AJ/Se 28 May 2008 Page 1 of 16 Dossier for the Scientific Substantiation of Claims related to Palatinose (isomaltulose) and its Nutritional / Physiological Properties Table of Content Summary 1. Isomaltulose – What it is! 2. Its Physiology – Digestion, Absorption & Metabolism of Isomaltulose 3. Studies on the Effect of Isomaltulose on Blood Glucose and Insulin Levels and its Prolonged Energy Supply 4. Discussion: General Characteristics of the Gycemic and Insulinemic Properties of Isomaltulose as compared to Sucrose 5. Conclusions Summary Isomaltulose is a disaccharide and – like sucrose – consists of glucose and fructose. But unlike sucrose, isomaltulose has low glycemic and low insulinemic properties. It is characterised by an α-1,6 glucosidic linkage between the glucose and fructose moieties which is more stable than the α-1,2 glucosidic linkage in sucrose. Isomaltulose is almost completely hydrolysed in the small intestine into its components glucose and fructose which are absorbed and metabolised in the same pathway as if derived from sucrose. Therefore, isomaltulose provides the same amount of calories as other fully available carbohydrates do (4 kcal/g in food labelling). The difference to sucrose is that isomaltulose is hydrolysed at a much lower rate which is reflected in its glycemic and insulinemic properties. The rise in blood glucose concentrations after isomaltulose intake is slower and remains at a lower level while it lasts for a longer period of time compared to sucrose. The insulin response corresponds, which results in a lower insulin demand. As no significant amounts of isomaltulose reach the large intestine, isomaltulose is tolerated as well as sucrose. Reflecting these characteristics in digestion and absorption, the uniqueness of isomaltulose when compared to sucrose and other available carbohydrates (e.g. maltodextrin) becomes obvious: Isomaltulose provides glucose, the fuel or energy for the body, in a more balanced and prolonged way. WHO recommends following a high-carbohydrate-based but low glycemic diet for a healthy lifestyle. Isomaltulose can contribute significantly to reach such a healthy lifestyle.
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Comision Federal de la mejora regul
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Subject: MEXICO - Comments on PROY
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Item of PROY‐ NOM‐051 A.3.1 & A
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Annex 1.1: Ziesenitz, S.C.; 1996;
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Volume 61 Supplement 1 December 200
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Volume 61, Supplement 1, December 2
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S1 S5 S19 S40 S75 S100 S112 S122 S1
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FAO/WHO Scientific Update on carboh
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cardiovascular diseases and cancer)
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REVIEW Carbohydrate terminology and
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Table 2 Energy and macronutrient in
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are inulin and fructo oligosacchari
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Table 3 Principal physiological pro
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National Academy of Sciences in 200
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product contained X25% whole grain
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Henderson L, Gregory J, Swan G (200
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REVIEW Nutritional characterization
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Table 1 Nutritional characterizatio
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Table 2 Principles of carbohydrate
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Table 4 NSP in a selection of foods
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asked to consider both the ‘plant
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Table 5 Continued Plant-rich diet a
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account for any supplemented materi
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eaction vessels, with successive tr
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similar to the situation with sugar
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company working on dietary carbohyd
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van Dam RM, Seidell JC (2007). Carb
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2003). In establishing the energy v
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combustible energy of the fermentab
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glucose, starch, NSP) there is also
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generated through bioenergetic inef
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Table 4 cE, ME and NME, and content
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ME (Atwater general system) (Merill
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(o0.8 kg in the adult), increase af
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B1.4 MJ from protein in men, did no
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food and body weight, height or BMI
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esults may relate not only to the d
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ecologist, who is pre-occupied with
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Table 5 Effect of NSP (dietary fibr
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As already described, almost any ca
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in adolescents. Possible mechanisms
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unit, such as a grant or fellowship
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Conference on Medical Research. Ros
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Prentice AM, Poppitt SD (1996). Imp
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REVIEW Carbohydrate intake and obes
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Total carbohydrate intake Introduct
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composition of the diet did not sub
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European Journal of Clinical Nutrit
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postmenopausal US women (Howard et
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weight loss was greater after 6 mon
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European Journal of Clinical Nutrit
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its carbohydrate content, whereas a
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Table 4 Continued Duration Interven
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Despite a substantially lower GL fo
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increased physical activity has bee
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with normal glucose tolerance: the
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Westerterp KR, Verboeket-van de Ven
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especially the NSP, complicates com
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1.21, 1.35, 1.40 and 1.64. The patt
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Page 140 and 141: There is no good evidence of benefi
Page 142 and 143: Meyer KA, Kushi LH, Jacobs Jr DR, S
Page 144 and 145: from prospective studies which have
Page 146 and 147: Table 3 Prospective studies of diet
Page 148 and 149: of sucrose-containing foods, such a
Page 150 and 151: Acrylamide Acrylamide is a chemical
Page 152 and 153: Nicodemus KK, Jacobs Jr DR, Folsom
Page 154 and 155: carbohydrate and fat may have a low
Page 156 and 157: Foods having very different nutrien
Page 158 and 159: esearch activities and food selecti
Page 160 and 161: highest satiety score was boiled po
Page 162 and 163: patients: a new basis for carbohydr
Page 164 and 165: and lipid levels, to a greater exte
Page 166 and 167: insufficient for the use of glycaem
Page 168 and 169: Dr Hans Englyst: Director and share
Page 175 and 176: Annex 1.4: US‐FDA GRAS Notificati
Page 177 and 178: FDA/CFSAN/OFAS: Agency Response Let
Page 179 and 180: Annex 1.5: US Health Claims Regulat
Page 181 and 182: jlentini on PROD1PC65 with RULES 30
Page 183 and 184: Annex 1.6: “PalatinoseTM (isomalt
Page 185: Isomaltulose is tooth friendly, unl
Page 189 and 190: CONFIDENTIAL General or usual name:
Page 191 and 192: CONFIDENTIAL Regulatory Affairs & N
Page 193 and 194: CONFIDENTIAL Plasma glucose change
Page 197 and 198: CONFIDENTIAL Rise in blood glucose
Page 201 and 202: CONFIDENTIAL References Regulatory
Page 203: Annex 1.8: Report from Imfeld (Univ
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Annex 2.2: Roberfroid, M.B., 1999;
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Annex 3.2: “Letter of no objectio
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1 Nutrition and Health Claims (CAC/
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Annex 3.2: “Letter of no objectio
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