Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes (NCT07124585) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes
Malaysia33 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range30 Years – 50 Years
SexMALE
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Inclusion criteria
✓. 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.
✓. Currently on oral antidiabetic medications and not on insulin.
✓. Initial HbA1c less than 10%.
✓. Patients with other stable, non-severe chronic conditions (e.g., hypertension, dyslipidemia) may be included if they have been on a stable prescribed oral treatment for at least 6 months.
✓. Patients who have undergone dietary counselling for diabetes and are willing to maintain their habitual diabetes-friendly diet and usual physical activity patterns throughout the study period.
. 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.
✕. Special dietary practices (e.g., intermittent fasting, vegetarian, ketogenic diet) that deviate from typical Malaysian dietary patterns.
✕. Treatment with glucocorticoids, antibiotics or other medications and food supplements (e.g. probiotics) that can significantly alter intestinal function and gut microbiome.
✕. Involvement in clinical trials within the last 3 months.