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

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.

Chronic sucralose consumption induces elevation of serum insulin in young healthy adults: a randomized, double blind, controlled trial

“…However, emerging evidence in obese individuals [10] and mice [11] has now suggested that NNS ingestion is directly associated with altered insulin response during oral glucose tolerance test (OGTT), especially with sucralose. In contrast, other studies have found contradictory results, where sucralose consumption had no effect on insulin or glucose responses during OGTT [14][15][16]. Although multiple mechanisms including gut microbiota dysbiosis and orosensory stimulation may explain these apparently contradictory results [11,17,18], it is still unknown whether frequent sucralose consumption can directly disrupt the metabolic homeostasis in humans.…”

Association of artificially sweetened and sugar-sweetened soft drinks with β-cell function, insulin sensitivity, and type 2 diabetes: the Maastricht Study

“…These discrepant findings may be caused by differences in research methodology, i.e., three studies focused on fasting insulin sensitivity only [4][5][6] and two studies excluded newly diagnosed T2D from analyses [5,7]. In addition, however, randomized controlled trials so far have not been able to detect any effects of artificial sweeteners on glucose metabolism [30,31]. Therefore, future studies are necessary to confirm our results.…”

Content Validity and Reliability of a Food Frequency Questionnaire with Intense Sweeteners (FFQIS) in a Hispanic Population

“…Their caloric content is below that of many other food products, offering a real possibility for weight control among consumers. However, new studies in young adults have revealed association between non-caloric sweeteners intake and the increase of accumulated abdominal fat, metabolic diseases, hypertension, insulin resistance and diabetes type 2, [7][8][9] which have not been confirmed by others [10].…”