Durian Consumption in Adults With Type 2 Diabetes Mellitus

NCT07697612 | Not Yet Recruiting

• 2 other identifiers: DURIOME-T2D-012025-1745
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Durian; Gut Microbiome; Metabolome; Continuous Glucose Monitoring; Precision Nutrition; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  During pre-durian, durian, and post-durian phases, each approximately 10 to 14 days

Secondary Outcomes (3)

• Change in fasting plasma glucose

  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

  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

  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

Study Arms (1)

Durian pulp

EXPERIMENTAL

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.

Dietary Supplement: Durian pulp

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.

Durian pulp

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 to 70 years.
• Diagnosis of type 2 diabetes mellitus.
• Agrees to consume durian for 2 weeks.
• Body mass index 25 to 40 kg/m².

You may not qualify if:

• Known or suspected intolerance or allergy to durian.
• Known skin reaction to adhesives used in a continuous glucose sensor.
• Uncontrolled diabetes (HbA1c greater than 8.5%).
• Severe hypertriglyceridemia (triglycerides greater than 4.5 mmol/L).
• Smoking.
• Previous gastrointestinal surgeries, including cholecystectomy, gastrectomy, bariatric surgery, or colectomy.
• Inflammatory bowel disease.
• Glomerular filtration rate less than 30 mL/min.
• ALT greater than 3 times upper limit of normal.
• AST greater than 3 times upper limit of normal.
• Liver cirrhosis.
• Significant alcohol consumption, defined as more than 20 g/day for women and more than 30 g/day for men.
• Pregnant, breastfeeding, or intending to conceive during the study.
• Current hemorrhoids or piles causing rectal bleeding during stool passage.
• Systemic steroid use.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Hong Chang Tan, MD, PhD

CONTACT

+65-6222 3322; tan.hong.chang@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All enrolled participants undergo the same sequence of study phases: pre-durian, durian consumption, and post-durian.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)