A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis
Open accessAbstract
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.
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Nonnutritive sweeteners do not appear to have a significant effect on glycemic management.
“Nonnutritive sweeteners do not appear to have a significant effect on glycemic management (97,230,231), and they can reduce overall calorie and carbohydrate intake (97,228) as long as individuals are not compensating with additional calories from other food sources (70,232).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [230]
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YAPAY TATLANDIRICILARIN SAĞLIKLI BESLENME VE HELAL GIDA AÇISINDAN DEĞERLENDİRİLMESİ
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- Authors
- Grotz, V. L., Pi-Sunyer, X., Porte, D., Roberts, A., & Richard Trout, J.
- Affiliations
- Columbia University Irving Medical Center (US)
- University of California San Diego (US)
- Intertek (Canada) (CA)
- Corresponding author
- Grotz, V. Lee
- Venue
- Regulatory Toxicology and Pharmacology
- Publisher
- Elsevier BV
- Published
- 2017-08
- Volume
- 88
- Pages
- 22-33
- ISSN
- 0273-2300 (ISSN-L)
- OpenAlex
- W2613545337
- Cited by
- 68
- References
- 52
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 4 · 2023: 3 · 2022: 5 · 2021: 14 · 2020: 13 · 2019: 14 · 2018: 6 · 2017: 1
- FWCI
- 7.73
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Regulatory Toxicology and Pharmacology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Biochemical Analysis and Sensing Techniques
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diet, Metabolism, and Disease
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Natural Antidiabetic Agents Studies
- Keywords
- sucralose, artificial sweeteners, glucose homeostasis, glycemic control, insulin, C-peptide, HbA1c, oral glucose tolerance test, fasting blood glucose
- MeSH terms
- Blood Glucose, C-Peptide, Diabetes Mellitus, Type 2, Double-Blind Method, Fasting, Glycated Hemoglobin, Homeostasis, Humans, Insulin, Male, Sucrose, Sweetening Agents
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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