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Tan HS, Gilcharan Singh HK, Misra S, Mariappan V, Jamil @ A. Wahab NA, Mustapa SN
Short-Term Effects of Nonnutritive Sweetener (Sucralose and Saccharin) Consumption on Glycemic Control and Gut Microbiota in Patients With Type 2 Diabetes: Protocol for a Double-Blind, Randomized, Placebo-Controlled, Crossover Trial
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients: Study Protocol for a Double-Blind, Randomised, Placebo-Controlled, Crossover Trial
Huey Shin Tan;
Harvinder Kaur Gilcharan Singh;
Snigdha Misra;
Vanitha Mariappan;
Nor Aini Jamil @ A. Wahab;
Suhaili Naim Mustapa
ABSTRACT
Background:
Non-nutritive sweeteners (NNS) are widely used as sugar substitutes to help individuals with diabetes manage glycaemic control. However, emerging evidence suggests that even low doses of NNS, such as saccharin and sucralose, may adversely affect metabolic health by impairing glycaemic regulation. These effects appear to be mediated, in part, by changes in the gut microbiome. In Malaysia, where gut microbiome research is still limited, particularly among individuals with Type 2 Diabetes Mellitus (T2DM) further investigation is needed to inform guidelines for NNS use.
Methods:
This is a double-blind, randomised, placebo-controlled, crossover trial designed to evaluate the short-term effects of saccharin and sucralose on glycaemic control and the gut microbiota. A total of 33 adults with T2DM will consume sucralose (5 mg/kg body weight), saccharin (2 mg/kg body weight), or a placebo (calcium carbonate) in capsule form daily for seven days in each intervention arm with a month wash-out period. Data collection will include anthropometric measurements, biochemical assessment for glycaemic control, dietary food records, physical activity levels, and stool samples for 16S rRNA gene sequencing to assess gut microbiota composition. This trial is registered at ClinicalTrials.gov (NCT07124585).
Discussion: This trial will contribute novel insights into the effects of short-term NNS consumption on glycaemic control and gut microbiota composition in individuals with T2DM. This finding may support evidence-based recommendations for NNS use in diabetes management and enhance understanding of microbiome-diet interactions in an ethnically diverse Asian population.
Citation
Please cite as:
Tan HS, Gilcharan Singh HK, Misra S, Mariappan V, Jamil @ A. Wahab NA, Mustapa SN
Short-Term Effects of Nonnutritive Sweetener (Sucralose and Saccharin) Consumption on Glycemic Control and Gut Microbiota in Patients With Type 2 Diabetes: Protocol for a Double-Blind, Randomized, Placebo-Controlled, Crossover Trial