A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis

Publication Name: Regul Toxicol Pharmacol. 2017 May 11;88:22-33. doi: 10.1016/j.yrtph.2017.05.011. [Epub ahead of print]

Author(s): Grotz VL, Pi-Sunyer X, Porte D Jr, Roberts A, Richard Trout J. | Publication Year: 2017

Abstract

The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ?333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control.

Summary

This paper provides an overview of the available scientific literature regarding sucralose effect on glucose control and further presents the outcomes of a 12-week, double-blind, parallel-group randomised controlled trial in 47 normoglycemic male participants which showed that daily consumption of sucralose had no impact on blood glucose control. With regard to the trial’s findings, fasting or post-prandial glucose, insulin, C-peptide and glycosylated hemoglobin (HbA1c) were not statistically different between sucralose and control groups. The authors conclude that this study corroborates collective evidence that daily consumption of sucralose is without effect on blood glucose control.

Numerous studies in humans, including the study reported in this paper, and more recent studies in animals provide strong evidence that sweet taste signal transduction as a result of sucralose consumption does not lead to clinically meaningful effects on blood glucose. This information is valuable to both health care professionals and the general public in considering the potential benefits of using low calorie sweeteners as a means to reduce sugar intake.