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

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 sucralos...

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Bibliographic Details
Published in:Regulatory toxicology and pharmacology 2017-08, Vol.88, p.22-33
Main Authors: Grotz, V. Lee, Pi-Sunyer, Xavier, Porte, Daniel, Roberts, Ashley, Richard Trout, J.
Format: Article
Language:English
Subjects:
Blood Glucose - analysis
Blood Glucose - drug effects
C-Peptide - blood
Diabetes Mellitus, Type 2
Double-Blind Method
Fasting - blood
Glucose homeostasis
Glycated Hemoglobin A - analysis
Healthy volunteers
Homeostasis - drug effects
Humans
Insulin - blood
Male
OGTT
Sucralose
Sucrose - analogs & derivatives
Sucrose - blood
Sucrose - pharmacology
Sweetening Agents - pharmacology
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Summary: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. •Gut taste receptor research has led to questions on low calorie sweeteners in glycemic control.•Effects have been hypothesized based mostly on cellular and/or short-term animal studies.•Reported is a 12-week clinical trial investigating the effects of sucralose on glycemic control.•Sucralose had no effect on fasting or post-prandial glucose, insulin and C-peptide, or HbA1c.•The collective evidence is reviewed and supports that sucralose is without effect on glycemia.
ISSN:0273-2300
1096-0295
DOI:10.1016/j.yrtph.2017.05.011