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

Launched by NATIONAL UNIVERSITY OF MALAYSIA · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how two common artificial sweeteners, saccharin and sucralose, affect blood sugar levels and gut bacteria in adults with Type 2 Diabetes. Since these sweeteners are often used instead of sugar to help manage blood sugar, researchers want to see if even short-term use might change how the body controls sugar or affect the helpful bacteria living in the gut. The study will include 33 Malay men aged 30 to 50 who have been living with Type 2 Diabetes for 1 to 5 years, are slightly overweight, and are taking oral diabetes medications but not insulin.

Participants will take capsules containing saccharin, sucralose, or a placebo (a harmless substance) each day for a week, with breaks in between. The study is designed so that neither the participants nor the researchers know which capsule is being taken at any time, to keep the results unbiased. During the trial, participants will provide blood and stool samples and share information about their diet and activity. This will help the researchers understand if these sweeteners influence blood sugar control or the gut bacteria. Those interested should be willing to maintain their usual diabetes-friendly diet and avoid alcohol during the study. The findings may help improve dietary advice for people with Type 2 Diabetes, especially within the Malaysian population.

Gender

MALE

Eligibility criteria

• • Inclusion criteria This study aims to recruit a cohort of patients with early-phase diagnosed T2DM whose conditions are stable that can best represent the Malaysian DM phenotypes.
• • 1. Malay Male citizens of Malaysia.
• • 2. Aged between 30 and 50 years.
• • 3. BMI between 23-27.4 kg/m² (Overweight).
• • 4. Diagnosed with diabetes for a duration between 1-5 years.
• • 5. Currently on oral antidiabetic medications and not on insulin.
• • 6. Initial HbA1c less than 10%.
• • 7. 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.
• • 8. 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.
• • 9. Willing to refrain from alcohol throughout the study period.
• • 10. Must be literate in English or Bahasa Malaysia.
• • Exclusion criteria The exclusion criteria will primarily focus on lifestyle behaviours or dietary practices that deviate from typical Malaysian lifestyles and while also considering behaviours that could significantly alter the gut microbiota.
• • 1. Current smoking, alcohol use, or drug abuse.
• • 2. Experienced more than a 5% change in body weight within the past 3 months.
• • 3. Acute illness or significant cardiovascular, psychological, neurological, renal, or endocrine diseases, apart from diabetes.
• • 4. Intolerance or allergy to test products.
• • 5. Special dietary practices (e.g., intermittent fasting, vegetarian, ketogenic diet) that deviate from typical Malaysian dietary patterns.
• • 6. Treatment with glucocorticoids, antibiotics or other medications and food supplements (e.g. probiotics) that can significantly alter intestinal function and gut microbiome.
• • 7. Involvement in clinical trials within the last 3 months.