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.
Durian is a widely consumed tropical fruit with high fiber content and multiple bioactive compounds, including phenolics, flavonoids, carotenoids, and volatile sulfur compounds. Although animal and limited human studies suggest possible metabolic effects, the impact of durian consumption on gut microbiota and host metabolomic profiles in adults with type 2 diabetes mellitus remains unclear. This single-arm interventional study will enroll 40 adults with T2DM at Singapore General Hospital. Participants will complete five study visits over approximately 1.5 to 3 months. After screening, eligible participants will enter a pre-durian phase, a durian phase, and a post-durian phase, each lasting 10 to 14 days. During the durian phase, participants will consume 100 g of durian on Day 1 and 200 g daily from Day 2 onward for 10 to 14 days. Continuous glucose monitoring will be performed across study phases. Blood samples will be analyzed for clinical laboratory parameters, inflammatory markers, metabolomics, and genetic/epigenetic analyses. Stool samples will undergo metagenomic sequencing and metabolomic analysis. The study hypothesis is that durian consumption will result in significant changes in the gut microbiome and metabolome of individuals with T2DM without adversely affecting gluometric measures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
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.
Singapore General Hospital
Singapore, Singapore
Change in gut microbiome composition following durian consumption
Gut microbiome composition will be assessed from stool samples using comprehensive metagenomic sequencing, comparing pre-durian, durian, and post-durian phases.
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
Change in plasma metabolomic profile following durian consumption
Plasma metabolomic changes will be assessed using mass spectrometry-based multi-omics profiling across study phases.
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
Change in glucose metrics during and after durian consumption
Continuous glucose monitoring data will be used to evaluate interstitial glucose patterns and gluometric parameters across study phases.
Time frame: During pre-durian, durian, and post-durian phases, each approximately 10 to 14 days
Change in fasting plasma glucose
Fasting glucose measured from blood samples across study visits.
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
Change in fasting insulin
Fasting insulin measured from blood samples across study visits.
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
Change in lipid profile
Lipid panel measured from fasting blood samples across study visits.
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
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