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

J Am Diet Assoc. 2003 Dec;103(12):1607-12. doi: 10.1016/j.jada.2003.09.021.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Analysis of Variance
  • Blood Glucose / drug effects*
  • Blood Glucose / metabolism
  • C-Peptide / blood
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / metabolism*
  • Double-Blind Method
  • Fasting
  • Female
  • Glycated Hemoglobin A / analysis*
  • Homeostasis / drug effects
  • Humans
  • Male
  • Middle Aged
  • Patient Compliance
  • Sucrose / administration & dosage
  • Sucrose / analogs & derivatives*
  • Sucrose / pharmacology*
  • Sweetening Agents / administration & dosage
  • Sweetening Agents / pharmacology*

Substances

  • Blood Glucose
  • C-Peptide
  • Glycated Hemoglobin A
  • Sweetening Agents
  • Sucrose
  • trichlorosucrose