Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers

NCT06194084 | Completed

• 1 other identifier: DURIOME
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.

Conditions

Diet, Food and Nutrition

Keywords

Precision Nutrition; Durian; Gut Microbiome; Metabolome

Outcome Measures

Primary Outcomes (14)

• Fasted Blood Glucose

  Changes in Fasted Blood Glucose (mg/dL), before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• HbA1C

  Changes in HbA1C (%) before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Total Cholesterol

  Changes in Total Cholesterol (mg/dL) before \& after Durian Intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• HDL Cholesterol

  Changes in HDL Cholesterol (mg/dL) before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• LDL Cholesterol

  Changes in LDL Cholesterol (mg/dL) before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Cholesterol/HDL Ratio

  Changes in Cholesterol/HDL ratio before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Triglycerides

  Changes in Triglycerides (mg/dL) before \& after Durian intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Carbohydrates

  Food record for carbohydrate intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Protein

  Food record for protein intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Fats

  Food record for fat intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Dietary Fibre

  Food record for dietary fibre intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Cholesterol

  Food record for cholesterol intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Sodium

  Food record for sodium intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Sugar

  Food record for sugar intake.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

Secondary Outcomes (2)

• Changes in gut microbiome composition before and after Intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

• Changes in metabolomes before and after Intervention.

  Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).

Other Outcomes (1)

• Plasma Samples obtained from 50 healthy participants form different multi-ethnicity (Malays, Chinese and Indians) will be genotyped using a custom single nucleotide polymorphism (SNP) genotyping array (Illumina OncoArray-500K Bead Chip).

  Baseline.

Study Arms (1)

Intervention - durian pulp.

EXPERIMENTAL

Two-sequence of doses (100 g and 200 g) of durian pulp.

Other: Two-sequence of durian pulp doses (100 g and 200 g)

Interventions

Two-sequence of durian pulp doses (100 g and 200 g) OTHER

Participants first go through an initial washout maintaining a low-fiber diet for 14 days. After washout, participants will be instructed to consume 100 grams of durian pulp every day following their breakfast or dinner for 1 week. Participants will then continue to consume 200 grams of durian pulp every day during the 2nd week of intervention and then will go through another washout for 2 weeks.

Intervention - durian pulp.

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and/or female subjects between the ages of 21 and 60 years, inclusive
• Willing and able to provide written informed consent
• Must be in generally good health with clinically insignificant screening results (Fasting plasma glucose level \& Lipid profile), as determined by the Investigator
• Agrees to consume durian for 2 weeks
• Agrees to maintain a low-fiber diet during the intervention
• Have not received any antibiotics therapy, consumed prebiotics, probiotics, symbiotic /vitamin supplement, and/or TCM for at least 1 month before the start of the study
• Have not received any medical treatment that would impact on intestinal microbiota at least 6 months before the start of the study or during the study
• Recent COVID-19 vaccination received or infection with COVID-19 at least 2 months ago

You may not qualify if:

• Known or suspected sensitivity/allergy to durian
• Multiple food/drug allergies
• Smoker
• History or presence of current metabolic conditions and gastrointestinal diseases
• Diagnosed with Inflammatory Bowel Disease (IBD) or significant liver enzyme abnormality
• Presence of current haemorrhoids or piles causing rectal bleeding when passing stool
• Pregnant, breastfeeding or intending to conceive during study period

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead

Study Sites (1)

National Cancer Centre, Singapore

Singapore, 168583, Singapore

Location

Study Officials

• Jason YS CHAN, MD, PhD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: January 8, 2024
• Study Start: February 1, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

SG (1)