Durian pulp: Fresh durian pulp supplied by the study team. Participants consume 100 g on Day 1, then 200 g daily from Day 2 onward during the durian phase for 10 to 14 days. Participants record the timing and amount consumed each day.
Study summary
This single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Forty adults with T2DM will undergo a pre-durian phase, a durian consumption phase, and a post-durian phase, each lasting 10 to 14 days. Participants will attend five visits at Singapore General Hospital for clinical assessments, continuous glucose monitoring, fasting blood collection, stool sample collection, and dietary and stool record submission. The study aims to determine whether durian consumption alters microbiome and metabolomic profiles and whether it affects glycemic measures in adults with T2DM.
Eligibility
Sex
ALL
Min age
21 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 21 to 70 years.
2. Diagnosis of type 2 diabetes mellitus.
3. Agrees to consume durian for 2 weeks.
4. Body mass index 25 to 40 kg/m².
Exclusion Criteria:
1. Known or suspected intolerance or allergy to durian.
2. Known skin reaction to adhesives used in a continuous glucose sensor.
3. Uncontrolled diabetes (HbA1c greater than 8.5%).
4. Severe hypertriglyceridemia (triglycerides greater than 4.5 mmol/L).
5. Smoking.
6. Previous gastrointestinal surgeries, including cholecystectomy, gastrectomy, bariatric surgery, or colectomy.
7. Inflammatory bowel disease.
8. Glomerular filtration rate less than 30 mL/min.
9. ALT greater than 3 times upper limit of normal.
10. AST greater than 3 times upper limit of normal.
11. Liver cirrhosis.
12. Significant alcohol consumption, defined as more than 20 g/day for women and more than 30 g/day for men.
13. Pregnant, breastfeeding, or intending to conceive during the study.
14. Current hemorrhoids or piles causing rectal bleeding during stool passage.
15. Systemic steroid use.
16. Insulin use.
17. Weight loss medications, including GLP-1 receptor agonists, orlistat, or phentermine.
18. Antibiotic, prebiotic, probiotic, vitamin C, or traditional Chinese medicine use in the last 1 month.
19. Uncontrolled thyroid disease.
20. Any factor likely to limit adherence to study protocol, including dementia, substance abuse, poor appointment adherence, or family concerns regarding participation
Primary outcome measure(s)
Change in gut microbiome composition following durian consumption — Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start Gut microbiome composition will be assessed from stool samples using comprehensive metagenomic sequencing, comparing pre-durian, durian, and post-durian phases.
Change in plasma metabolomic profile following durian consumption — Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start Plasma metabolomic changes will be assessed using mass spectrometry-based multi-omics profiling across study phases.
Change in glucose metrics during and after durian consumption — During pre-durian, durian, and post-durian phases, each approximately 10 to 14 days Continuous glucose monitoring data will be used to evaluate interstitial glucose patterns and gluometric parameters across study phases.
Trial sites (1)
Facility
City
Region
Status
Singapore General Hospital
Singapore
Singapore
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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