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

V. Lee Grotz, Robert R. Henry, Janet B. Mcgill, Melvin J. Prince, Harry Shamoon, J. Richard Trout, F. Xavier Pi-Sunyer

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97 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1607-1612+1711
JournalJournal of the American Dietetic Association
Volume103
Issue number12
DOIs
StatePublished - Dec 2003

ASJC Scopus subject areas

  • Food Science
  • Nutrition and Dietetics

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    Grotz, V. L., Henry, R. R., Mcgill, J. B., Prince, M. J., Shamoon, H., Trout, J. R., & Pi-Sunyer, F. X. (2003). Lack of effect of sucralose on glucose homeostasis in subjects with type 2 diabetes. Journal of the American Dietetic Association, 103(12), 1607-1612+1711. https://doi.org/10.1016/j.jada.2003.09.021