NCT07124585Not yet recruiting
Short-Term Effects of Sucralose and Saccharin on Blood Sugar and Gut Microbiota in Type 2 Diabetes
Short-Term Effect of Non-Nutritive Sweeteners (Sucralose and Saccharin) Consumption on Glycaemic Control and Gut Microbiota in Type 2 Diabetes Patients
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 8 Aug 2025
- Start date
- 30 Jan 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- National University of Malaysia
- Diseases
- Type 2 diabetes
- NCT number
- NCT07124585
What you commit to
- Study type: Interventional
- Planned participants: 33
- From 30 Jan 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes.
- Intolerance or allergy to test products.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 30 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinik Kesihatan Setapak Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.