Status:
COMPLETED
Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Diet, Food and Nutrition
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.
Detailed Description
Participants will 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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06194084
Start Date
February 1 2023
End Date
August 29 2025
Last Update
October 1 2025
Active Locations (1)
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1
National Cancer Centre, Singapore
Singapore, Singapore, 168583