Diet, Food and NutritionDURIOMENCT06194084
Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers
A study testing Two-sequence of durian pulp doses (100 g and 200 g) in people with Diet, Food and Nutrition, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Food and Nutrition
- What is being tested?
- Two-sequence of durian pulp doses (100 g and 200 g)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2023to 29 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Two-sequence of durian pulp doses (100 g and 200 g)
- Keywords
- Precision Nutrition, Durian, Gut Microbiome, Metabolome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - durian pulp. | Experimental | Two-sequence of doses (100 g and 200 g) of durian pulp. Receives: Other: Two-sequence of durian pulp doses (100 g and 200 g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasted Blood Glucose
Changes in Fasted Blood Glucose (mg/dL), before \& after Durian intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Feb 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Food and NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason YS CHAN, MD, PhD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194084
- Sponsor's protocol ID
- DURIOME
- Acronym
- DURIOME
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Nutrition - Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers From SingHealth
- ClinicalTrials.gov ID
- NCT06194084
- Acronym / sponsor ID
- DURIOME / DURIOME
- Conditions
- Diet, Food and Nutrition
- Keywords
- Precision Nutrition, Durian, Gut Microbiome, Metabolome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention - durian pulp. | Experimental | Other: Two-sequence of durian pulp doses (100 g and 200 g)Two-sequence of doses (100 g and 200 g) of durian pulp. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention - durian pulp. |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Diet, Food and Nutrition
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
Training, Coaching and Marketing Program for Vegetable and Fruit Vendors in Markets to Improve Food Safety Practices and Vegetable and Fruit Intake Among Women 20-49 yr Old in Quezon City, Philippines
Intake of Fruit, Intake of Vegetables
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason YS CHAN, MD, PhD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-sequence of durian pulp doses (100 g and 200 g) in people with Diet, Food and Nutrition, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.