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Research| Volume 103, ISSUE 12, P1607-1612, December 2003

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Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes

DOI:https://doi.org/10.1016/j.jada.2003.09.021
Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes
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      Abstract

      Objective

      To investigate the effect of 3-months’ daily administration of high doses of sucralose, a non-nutritive sweetener, on glycemic control in subjects with type 2 diabetes.

      Design

      A multicenter, double-blind, placebo-controlled, randomized study, consisting of a 6-week screening phase, a 13-week test phase, and a 4-week follow-up phase.

      Subjects/setting

      Subjects with type 2 diabetes (age range 31 to 70 years) entered the test phase of this study; 128 subjects completed the study. The subjects were recruited from 5 medical centers across the United States and were, on average, obese.

      Intervention

      Subjects were randomly assigned to receive either placebo (cellulose) capsules (n=69) or 667 mg encapsulated sucralose (n=67) daily for the 13-week test phase. All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase.

      Main outcome measures

      Glycated hemoglobin (HbA1c), fasting plasma glucose, and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis. Data were analyzed by analysis of variance using repeated measures.

      Results

      There were no significant differences between the sucralose and placebo groups in HbA1c, fasting plasma glucose, or fasting serum C-peptide changes from baseline. There were no clinically meaningful differences between the groups in any safety measure.

      Conclusions

      This study demonstrated that, similar to cellulose, sucralose consumption for 3 months at doses of 7.5 mg/kg/day, which is approximately three times the estimated maximum intake, had no effect on glucose homeostasis in individuals with type 2 diabetes. Additionally, this study showed that sucralose was as well-tolerated by the study subjects as was the placebo.
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      References

        • Miller G.A.
        Sucralose.
        in: Nabor L.O. Gelardi R.C. Alternative Sweeteners. 2nd ed. Marcel Dekker, Atlanta, GA1991: 173-195
        View in Article
        • Jenner M.R.
        The uses and commercial development of sucralose.
        in: Grenby T.H. Advances in Sweeteners. Blackie Academic and Professional, Glasgow, UK1996: 253-262
        View in Article
        • Grice H.
        • Goldsmith L.
        Sucralose.
        Food Chem Toxicol. 2000; 38: S1-S6
        View in Article
        • Roberts A.
        • Renwick A.G.
        • Sims J.
        • Snodin D.J.
        Sucralose metabolism and pharmacokinetics in man.
        Food Chem Toxicol. 2000; 38: S31-S41
        View in Article
      5. Food Additives Permitted for Direct Addition to Food For Human Consumption.
        Federal Register. 1998; 63 (April 3): 16417-16433
        View in Article
      6. Food Additive Permitted for Direct Addition to Food for Human Consumption.
        Federal Register. 1999; 64 (August 12): 43908-43909
        View in Article

      7. Submissions to FDA: McNeil Specialty Products Company Food Additive Petition 7A3987 (Sucralose), 1987–1997. Available through Freedom of Information (FOI) and through McNeil Nutritionals, formerly McNeil Specialty Products Company.

        View in Article
        • Mezitis H.E.
        • Maggio C.A.
        • Koch P.
        • Quoddoos A.
        • Allison D.B.
        • Pi-Sunyer F.X.
        Glycemic effect of a single high oral dose of the novel sweetener sucralose in patients with diabetes.
        Diabetes Care. 1996; 19: 10004-10005
        View in Article
        • Toeller M.
        Diet and diabetes.
        Diabetes Metab Rev. 1993; 9: 93-108
        View in Article

      10. Submission to FDA: Exhibit B: Use. 1986 Market Research Corporation of America Intake Study. In McNeil Specialty Products Company Food Additive Petition 7A3987 (Sucralose), 1987. Available through Freedom of Information (FOI) and through McNeil Nutritionals, formerly McNeil Specialty Products Company.

        View in Article

      11. Submission to FDA: Exhibit B: Use. 1994 Market Research Corporation of America Intake Study. In McNeil Specialty Products Company Food Additive Petition 8A4624 (Sucralose), 1998. Available through Freedom of Information (FOI) and through McNeil Nutritionals, formerly McNeil Specialty Products Company.

        View in Article

      12. Submission to FDA: McNeil Specialty Products Company Internal Report No. E169: A 12 week study of the effect of sucralose on glucose homeostasis and HbA1c in normal healthy volunteers 1996. In McNeil Specialty Products Company Food Additive Petition 7A3987 (Sucralose). Available through Freedom of Information (FOI) and through McNeil Nutritionals, formerly McNeil Specialty Products Company.

        View in Article
        • McLean Baird I.
        • Shephard N.W.
        • Merritt R.J.
        • Hildick-Smith G.
        Repeated dose study of sucralose tolerance in human subjects.
        Food Chem Toxicol. 2000; 38: S123-S129
        View in Article
        • Knight I.
        The development and applications of sucralose, a new high-intensity sweetener.
        Can J Physiol Pharmacol. 1994; 72: 435-439
        View in Article
        • Barndt R.L.
        • Jackson G.
        Stability of sucralose in baked goods.
        Food Technology. 1990; 44: 62-66
        View in Article

      16. Submission to FDA: Exhibit B: Use. Appendix B007: Stability of sucralose to pasteurization in a ready to drink orange drink formulation. Appendix B008: Stability of sucralose in a model pasteurization process. In McNeil Specialty Products Company Food Additive Petition 7A3987 (Sucralose), 1987. Available through Freedom of Information (FOI) and through McNeil Nutritionals, formerly McNeil Specialty Products Company.

        View in Article
        • Wiet S.G.
        • Beyts P.K.
        Sensory characteristics of sucralose and other high intensity sweeteners.
        J Food Sci. 1992; 57: 1014-1019
        View in Article
        • Ludwig D.S.
        • Peterson K.E.
        • Gortmaker S.L.
        Relation between consumption of sugar-sweetened drinks and childhood obesity.
        Lancet. 2001; 357: 505-508
        View in Article
        • Bellisle F.
        • Rolland-Cachera M.F.
        How sugar-containing drinks might increase adiposity in children.
        Lancet. 2001; 357: 490
        View in Article
        • Harnack L.
        • Stang J.
        • Story M.
        Soft drink consumption among US children and adolescents.
        J Am Diet Assoc. 1999; 99: 436-441
        View in Article
        • Levine B.
        Childhood obesity associated with the excessive consumption of soft drinks and fruit juices.
        Topics Clin Nutr. 1997; 13: 69-73
        View in Article
        • Troiano R.P.
        • Flegal K.M.
        • Kuczmarski R.J.
        • Campbell S.M.
        • Johnson C.L.
        Overweight prevalence and trends for children and adolescents.
        Arch Pediatr Adolesc Med. 1995; 149: 1085-1091
        View in Article
        • Tordoff M.G.
        • Alleva A.M.
        Effect of drinking soda sweetened with aspartame or high-fructose corn syrup on food intake and body weight.
        Am J Clin Nutr. 1990; 51: 963-969
        View in Article
        • Drewnowski A.
        Energy density, palatability, and satiety.
        Nutr Rev. 1998; 56: 347-353
        View in Article
        • Quatromoni P.A.
        • Copenhafer D.L.
        • D’Agostino R.B.
        • Millen B.E.
        Dietary patterns predict the development of overweight in women.
        J Am Diet Assoc. 2002; 102: 1239-1246
        View in Article
        • Horton E.S.
        • Jeanrenaud B.
        Obesity and diabetes mellitus.
        in: Rifkin H. Porte D. Ellenberg and Rifkin’s Diabetes Mellitus Theory and Practice. 4th ed. Elsevier, New York, NY1990: 457-463
        View in Article
        • Raben A.
        • Vasilaras T.H.
        • Moller A.C.
        • Astrup A.
        Sucrose compared with artificial sweeteners.
        Am J Clin Nutr. 2002; 76: 721-729
        View in Article
        • Guthrie J.F.
        • Morton J.F.
        Food sources of added sweeteners in the diets of Americans.
        J Am Diet Assoc. 2000; 100: 43-48
        View in Article
        • Putnam J.J.
        • Allshouse J.E.
        Food Consumption, Prices, and Expenditures 1970–97. Food and Rural Economics Division, Economic Research Service, US Department of Agriculture, Washington, DC1999 (Statistical Bulletin No. 965.)
        View in Article
        • Centers for Disease Control and Prevention (CDC)
        Press release. 2002 (Available at: http://www.cdc.gov/nccdphp/dnpa/press/archive/diabetes_increase.htm. Accessed November 27)
        View in Article
        • Ludwig D.S.
        • Ebbeling C.B.
        Type 2 diabetes mellitus in children.
        JAMA. 2001; 286: 1427-1430
        View in Article

      Biography

      V. L. Grotz is director, Medical and Nutrition Affairs, McNeil Nutritionals, New Brunswick, NJ, USA

      Biography

      R. R. Henry is chief, Section of Diabetes, Endocrinology/Metabolism, University of California-San Diego, Division of Endocrinology/Metabolism, San Diego, CA, USA

      Biography

      J. B. McGill is associate professor of medicine, Washington University School of Medicine, Department of Internal Medicine, St Louis, MO, USA

      Biography

      M. J. Prince was senior clinical research physician, School of Medicine, Diabetes Research & Training Center, Indiana University, Indianapolis, IN, USA; and is now affiliated with Eli Lily, Lily Corporate Center, Indianapolis, IN, USA

      Biography

      H. Shamoon is associate dean for clinical research, Albert Einstein College of Medicine, Division of Endocrinology, Bronx, NY, USA

      Biography

      J. R. Trout is a statistical consultant, Rutgers University, New Brunswick, NJ, USA

      Biography

      F. X. Pi-Sunyer is chief of endocrinology, St. Luke’s-Roosevelt Hospital Center, Division of Endocrinology, Diabetes and Nutrition, New York, NY, USA

      Article info

      Footnotes

      ☆This study was supported by McNeil Specialty Products Company and Tate & Lyle Speciality Sweeteners.

      Identification

      DOI: https://doi.org/10.1016/j.jada.2003.09.021

      Copyright

      © 2003 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

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