Durian Consumption in Adults With Type 2 Diabetes Mellitus

Sponsor
Singapore General Hospital
Study ID
NCT07697612
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Durian pulp — DIETARY_SUPPLEMENT
    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 Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Durian pulp
    Adults with type 2 diabetes mellitus undergo a pre-durian observation phase, followed by daily durian consumption for 10 to 14 days, then a post-durian observation phase. All participants receive the same intervention and study procedures.

Primary Outcome Measure

Change in gut microbiome composition following durian consumption [ Time Frame: 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 ]

Central Contacts

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