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NOT YET RECRUITING
NCT07124585
NA

Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes

Sponsor: National University of Malaysia

View on ClinicalTrials.gov

Summary

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.

Official title: Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients

Key Details

Gender

MALE

Age Range

30 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-01-30

Completion Date

2027-07-31

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Sucralose

Participants 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.

DIETARY_SUPPLEMENT

Saccharin

Participants 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.

OTHER

Placebo (Calcium Carbonate)

Participants 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.

Locations (1)

Klinik Kesihatan Setapak

Kuala Lumpur, Malaysia