Testing Sucralose and Saccharin Effects on Blood Sugar in Type 2 Diabetes

Trial details

Who runs it

National University of Malaysia

Trial code

NCT07124585

Record updated

10 December 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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; Willing to refrain from alcohol throughout the study period; Must be literate in English or Bahasa Malaysia.

Exclusion: Current smoking, alcohol use, or drug abuse; Treatment with glucocorticoids, antibiotics or other medications and food supplements (e.g. probiotics) that can significantly alter intestinal function and gut microbiome; Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes; Intolerance or allergy to test products; Experienced more than a 5% change in body weight within the past 3 months; Special dietary practices (e.g., intermittent fasting, vegetarian, ketogenic diet) that deviate from typical Malaysian dietary patterns; Involvement in clinical trials within the last 3 months.

ClinicalTrials.gov NCT07124585