Format

Send to

Choose Destination
Regul Toxicol Pharmacol. 2017 Aug;88:22-33. doi: 10.1016/j.yrtph.2017.05.011. Epub 2017 May 11.

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

Author information

1
McNeil Nutritionals, Fort Washington, PA 19034, United States. Electronic address: lee.grotz@heartlandfpg.com.
2
Department of Medicine, Division of Endocrinology, Columbia University College of Physicians and Surgeons, New York, NY 10025, United States. Electronic address: fxp1@cumc.columbia.edu.
3
Department of Medicine, Division of Endocrinology and Metabolism, University of California San Diego, San Diego, CA, United States; Department of Medicine, Endocrinology, Diabetes and Metabolism Section, VA San Diego Health Care System, San Diego, CA, United States. Electronic address: dporte@ucsd.edu.
4
Food & Nutrition Group, Intertek Scientific & Regulatory Consultancy, Mississauga, Ontario, Canada. Electronic address: ashley.roberts@intertek.com.
5
Rutgers University, New Brunswick, NJ, United States. Electronic address: rtrout@rci.rutgers.edu.

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.

KEYWORDS:

Glucose homeostasis; Healthy volunteers; OGTT; Sucralose

PMID:
28502831
DOI:
10.1016/j.yrtph.2017.05.011
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center