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

NCT ID: NCT06194084

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-08-29

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 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. During the intervention period, participants will be informed to maintain low-fiber diet. All participants will be required to note down their stool consistency and stool frequency and 3-days dietary records. Stool and blood samples will be collected at 4 time points during the study period (baseline, 1-week of intervention, 2-weeks of intervention and 2-weeks washout) and will be stored at -80 °C until analysis.

The first outcomes of this study will provide insights into the interplay between durian consumption, gut microbiome, and host metabolome, as well as whether durian consumption can improve the clinical parameters (plasma glucose levels, lipid profiles and HbA1c levels) of healthy subjects. The interplay between diets, gut microbiome, host metabolome and genetic polymorphism data in healthy population will lay the groundwork to develop the precision nutrition strategy based on our regional food. These findings have potential to improve the health and well-being of the communities in our region.

Conditions

Diet, Food and Nutrition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention - durian pulp.

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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 Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Male and/or female subjects between the ages of 21 and 60 years, inclusive

2. Willing and able to provide written informed consent

3. Must be in generally good health with clinically insignificant screening results (Fasting plasma glucose level & Lipid profile), as determined by the Investigator

4. Agrees to consume durian for 2 weeks

5. Agrees to maintain a low-fiber diet during the intervention

6. 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

7. 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

8. Recent COVID-19 vaccination received or infection with COVID-19 at least 2 months ago

Exclusion Criteria

1. Known or suspected sensitivity/allergy to durian

2. Multiple food/drug allergies

3. Smoker

4. History or presence of current metabolic conditions and gastrointestinal diseases

5. Diagnosed with Inflammatory Bowel Disease (IBD) or significant liver enzyme abnormality

6. Presence of current haemorrhoids or piles causing rectal bleeding when passing stool

7. Pregnant, breastfeeding or intending to conceive during study period

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason YS CHAN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre, Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

DURIOME

Identifier Type: -

Identifier Source: org_study_id