This clinical trial investigates the short-term effects of two commonly used non-nutritive sweeteners (NNS), saccharin and sucralose, on blood glucose regulation and the gut microbiota in adults with Type 2 Diabetes Mellitus (T2DM). While NNS are widely promoted as sugar substitutes to aid glycaemic control, emerging evidence suggests that even small doses may influence metabolic health, potentially through interactions with the gut microbial community.
The study is designed as a double-blind, randomized, placebo-controlled, crossover trial involving 33 adults with T2DM. Each participant will receive all three interventions, saccharin, sucralose, and a placebo (calcium carbonate) in random order. Each intervention will be administered once daily in capsule form for 7 consecutive days, with a 4-week washout period between phases to minimize carryover effects.
Throughout the trial, data will be collected on anthropometry, blood-based glycaemic biomarkers, dietary intake, physical activity, and stool samples. Gut microbiota composition will be assessed via 16S rRNA gene sequencing.
The primary aim is to generate evidence on whether short-term exposure to NNS can affect glycaemic outcomes and gut microbial profiles in individuals with T2DM. The findings are expected to support future dietary recommendations on NNS use and improve our understanding of diet-microbiota-host interactions, particularly within Asian populations.
Male citizens of Malaysia.
Aged between 30 and 59 years.
BMI between 23-29.9 kg/m² (Overweight).
Diagnosed with diabetes for a duration between 1-10 years.
Current smoking, alcohol use, or drug abuse.
Experienced more than a 5% change in body weight within the past 3 months.
Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes.
Intolerance or allergy to test products.
Crossover
Sucralose
Dietary supplementParticipants will consume one capsule containing sucralose 5mg/kg body weight, with the dosage individualized according to body weight. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.
Saccharin
Dietary supplementParticipants will consume one capsule containing saccharin 2mg/kg body weight, with the dosage individualized according to body weight. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.
Placebo (Calcium Carbonate)
Other interventionParticipants will consume one capsule per day, containing a fixed dose of 500 mg. The capsule will be taken once daily in the morning, after breakfast, with plain water. This intervention will last for seven consecutive days.
Glycaemic control
The primary outcome of this study is to assess the change in glycaemic control, measured by insulin sensitivity using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which will be calculated from fasting glucose and insulin levels following NNS consumption
Gut microbiota composition and diversity
The secondary outcome is to evaluate changes in gut microbiota composition and diversity following NNS consumption. Microbiota outcomes will be assessed via 16S rRNA gene sequencing. Alpha diversity and beta diversity metrics will be used to evaluate within- and between-group microbiota differences. Differential abundance analysis will be conducted to identify specific taxanomy associated with each intervention.
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National University of Malaysia
Lead sponsor
Monash University Malaysia
Collaborator
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