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

September 25, 2025 updated by: National Cancer Centre, Singapore

Precision Nutrition - Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers From SingHealth

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Centre, Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention - durian pulp.
Two-sequence of doses (100 g and 200 g) of durian pulp.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasted Blood Glucose
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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
Time Frame: 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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in gut microbiome composition before and after Intervention.
Time Frame: 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).
The effect of intervention on alpha and beta diversity of the fecal microbial community will be evaluated by 16s sequencing (using illumina MiSeq platforms) of feal bacterial DNA at baseline and after each intervention period.
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.
Time Frame: 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 the plasma metabolomics will be evaluated via LC-QTOF-MS to identify the metabolomic markers at baseline and after each intervention period. Whereas changes in fecal microbial metabolomic will be determined via GC-QTOF-MS at baseline and after each intervention period.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: Baseline.
The association between the SNP in distinct ethnic groups and gut microbiome patterns will be investigated.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Centre, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason YS CHAN, MD, PhD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DURIOME

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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