JMIR Publications

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.

Objective:

This study aims to evaluate the short-term effects of saccharin and sucralose on glycaemic control and the gut microbiota.

Methods:

This is a double-blind, randomised, placebo-controlled, crossover trial. 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 four-week washout period between arms. Data collection will include anthropometric measurements, biochemical assessments of glycaemic control, dietary records, physical activity levels, and stool samples for 16S rRNA gene sequencing to assess gut microbiota composition.

Results:

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Conclusions:

This trial will provide novel insights into the short-term effects of NNS consumption on glycaemic control and gut microbiota composition in individuals with T2DM. The findings may support evidence-based recommendations for NNS use in diabetes management and enhance understanding of microbiome–diet interactions in an ethnically diverse Asian population. Clinical Trial: Registered at ClinicalTrials.gov (NCT07124585).