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

作者：Grotz V Lee^*; Pi Sunyer Xavier; Porte Daniel Jr; Roberts Ashley; Trout J Richard

来源：Regulatory Toxicology and Pharmacology, 2017, 88: 22-33.

DOI：10.1016/j.yrtph.2017.05.011

• Sucralose
• Glucose homeostasis
• OGTT
• Healthy volunteers

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 similar to 333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbAlc, 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 HbAlc 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 HbAlc, 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.

• 出版日期2017-8
• 单位rutgers