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CONFIDENTIAL Regulatory Affairs & Nutrition Communication – AJ/Se 28 May 2008 Page 6 of 16 3. Studies on the Effect of Isomaltulose on Blood Glucose and Insulin Levels and its Prolonged Energy Supply The slower hydrolysis of isomaltulose and subsequent slower absorption of glucose and fructose compared to sucrose are reflected in its characteristic blood glucose response with a slow, low and sustained rise in blood glucose levels and corresponding low insulin levels. Blood glucose and insulin response studies The effect of isomaltulose on blood glucose and insulin levels was studied in healthy and diabetic humans (Macdonald & Daniel 1983; Kawai et al 1985 and 1989, Sydney University’s Glycaemic Index Research Service (SUGiRS), 2002). In all the studies similar study designs were used for blood glucose and insulin measurements e.g. intake of the test and control substances dissolved in water and after overnight fasting. The most recent study at Sydney University’s Glycaemic Research Service (SUGiRS, 2002) – one of the leading research institutes in this scientific area - was performed to determine the Glycemic Index (GI) and the Insulinemic Index (II) of isomaltulose according to internationally recognised standard methodology 1 . In this study, 10 healthy volunteers (Caucasian, 18-24 years old, BMI of 19-24 kg/m 2 ) received 50 g isomaltulose or sucrose, maltodextrine, or glucose (control) dissolved in 250 ml water after overnight fasting. Blood glucose and insulin concentrations were determined over a period of 120 minutes. The blood glucose and insulin curves for isomaltulose and sucrose are shown in Figures 3 and 4. Blood glucose concentration after sucrose intake increased by a maximum of almost 4 mmol/l (76 mg/dl) within 30 minutes, while they returned to baseline after about 60 minutes followed by a phase below baseline (relative hypoglycaemia) for the most of the second hour of the measurement. In contrast, blood glucose concentrations after isomaltulose increased by less than a third of that of sucrose (1,2 mmol/l or 22 mg/dl) and remained above baseline for most of the duration of the two hour experiment. The insulin curves corresponded. The overall blood glucose and insulin responses were lower for isomaltulose than for sucrose as reflected by the corresponding GI and II values shown in Table 2. 1 The Glycemic Index (GI) is defined by FAO/WHO (1998) as the incremental area under the blood glucose response curve (IAUC) of a 50g carbohydrate portion of a test food expressed as a percentage of the response to the same amount of carbohydrate from a standard food (typically glucose or white bread) taken by the same subject. The Insulinemic Index (II) can be determined for the insulin curve, respectively.
CONFIDENTIAL Plasma glucose change (mmol/L) 5 4 3 2 1 0 -1 -2 Regulatory Affairs & Nutrition Communication – AJ/Se 28 May 2008 Page 7 of 16 0 30 60 90 120 Time (min) Sucrose Palatinose Figure 3: Blood glucose curves of isomaltulose (Palatinose or sucrose (50g) determined in 10 healthy volunteers at the Sydney University’s Glycaemic Index Research Service (2002), (mean±SD). Plasma insulin change (pmol/L) 350 300 250 200 150 100 50 0 -50 0 30 60 90 120 Time (min) Sucrose Palatinose Figure 4: Plasma insulin curves of isomaltulose (Palatinose) or sucrose (50g) determined in 10 healthy volunteers at the Sydney University’s Glycaemic Index Research Service (2002), (mean±SD).
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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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esidual confounding provide the jus
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carbohydrate have generated broadly
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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
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Page 160 and 161: highest satiety score was boiled po
Page 162 and 163: patients: a new basis for carbohydr
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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 and 186: Isomaltulose is tooth friendly, unl
Page 187 and 188: CONFIDENTIAL Regulatory Affairs & N
Page 189 and 190: CONFIDENTIAL General or usual name:
Page 191: CONFIDENTIAL Regulatory Affairs & N
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
Page 240: 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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