Type 2 DiabetesDURIOME-T2DNCT07697612
Durian Consumption in Adults With Type 2 Diabetes Mellitus
A study testing Durian pulp in people with Type 2 Diabetes, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Durian pulp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 70 years.
- Diagnosis of type 2 diabetes mellitus.
- Agrees to consume durian for 2 weeks.
- Body mass index 25 to 40 kg/m².
Who cannot join
- Known or suspected intolerance or allergy to durian.
- Known skin reaction to adhesives used in a continuous glucose sensor.
- Uncontrolled diabetes (HbA1c greater than 8.5%).
- Severe hypertriglyceridemia (triglycerides greater than 4.5 mmol/L).
- Smoking.
- Previous gastrointestinal surgeries, including cholecystectomy, gastrectomy, bariatric surgery, or colectomy.
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- Inflammatory bowel disease.
- Glomerular filtration rate less than 30 mL/min.
- ALT greater than 3 times upper limit of normal.
- AST greater than 3 times upper limit of normal.
- Liver cirrhosis.
- Significant alcohol consumption, defined as more than 20 g/day for women and more than 30 g/day for men.
- Pregnant, breastfeeding, or intending to conceive during the study.
- Current hemorrhoids or piles causing rectal bleeding during stool passage.
- Systemic steroid use.
- Insulin use.
- Weight loss medications, including GLP-1 receptor agonists, orlistat, or phentermine.
- Antibiotic, prebiotic, probiotic, vitamin C, or traditional Chinese medicine use in the last 1 month.
- Uncontrolled thyroid disease.
- Any factor likely to limit adherence to study protocol, including dementia, substance abuse, poor appointment adherence, or family concerns regarding participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore General Hospital
Singapore
Hong Chang Tan, MD PhD, 6222 3322, tan.hong.chang@singhealth.com.sg
Hong Chang Tan, MD PhD
About this study
Official title: Durian Consumption on Human Microbiome and Metabolome in Adults With Type 2 Diabetes Mellitus (DURIOME-T2D)
This single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Forty adults with T2DM will undergo a pre-durian phase, a durian consumption phase, and a post-durian phase, each lasting 10 to 14 days. Participants will attend five visits at Singapore General Hospital for clinical assessments, continuous glucose monitoring, fasting blood collection, stool sample collection, and dietary and stool record submission. The study aims to determine whether durian consumption alters microbiome and metabolomic profiles and whether it affects glycemic measures in adults with T2DM.
Read the detailed description
Durian is a widely consumed tropical fruit with high fiber content and multiple bioactive compounds, including phenolics, flavonoids, carotenoids, and volatile sulfur compounds. Although animal and limited human studies suggest possible metabolic effects, the impact of durian consumption on gut microbiota and host metabolomic profiles in adults with type 2 diabetes mellitus remains unclear. This single-arm interventional study will enroll 40 adults with T2DM at Singapore General Hospital. Participants will complete five study visits over approximately 1.5 to 3 months. After screening, eligible participants will enter a pre-durian phase, a durian phase, and a post-durian phase, each lasting 10 to 14 days. During the durian phase, participants will consume 100 g of durian on Day 1 and 200 g daily from Day 2 onward for 10 to 14 days. Continuous glucose monitoring will be performed across study phases. Blood samples will be analyzed for clinical laboratory parameters, inflammatory markers, metabolomics, and genetic/epigenetic analyses. Stool samples will undergo metagenomic sequencing and metabolomic analysis. The study hypothesis is that durian consumption will result in significant changes in the gut microbiome and metabolome of individuals with T2DM without adversely affecting gluometric measures.
- Conditions
- Type 2 Diabetes
- Being tested
- Durian pulp
- Keywords
- Durian, Gut Microbiome, Metabolome, Continuous Glucose Monitoring, Precision Nutrition, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durian pulpDietary supplement
Fresh durian pulp supplied by the study team. Participants consume 100 g on Day 1, then 200 g daily from Day 2 onward during the durian phase for 10 to 14 days. Participants record the timing and amount consumed each day.
| Study group | Role | What they receive |
|---|---|---|
| Durian pulp | Experimental | Adults with type 2 diabetes mellitus undergo a pre-durian observation phase, followed by daily durian consumption for 10 to 14 days, then a post-durian observation phase. All participants receive the same intervention and study procedures. Receives: Dietary Supplement: Durian pulp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiome composition following durian consumption
Gut microbiome composition will be assessed from stool samples using comprehensive metagenomic sequencing, comparing pre-durian, durian, and post-durian phases.
Measured: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in plasma metabolomic profile following durian consumption
Plasma metabolomic changes will be assessed using mass spectrometry-based multi-omics profiling across study phases.
Measured: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in glucose metrics during and after durian consumption
Continuous glucose monitoring data will be used to evaluate interstitial glucose patterns and gluometric parameters across study phases.
Measured: During pre-durian, durian, and post-durian phases, each approximately 10 to 14 days
Secondary outcomes (3)
Change in fasting plasma glucose
Fasting glucose measured from blood samples across study visits.
Measured: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in fasting insulin
Fasting insulin measured from blood samples across study visits.
Measured: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in lipid profile
Lipid panel measured from fasting blood samples across study visits.
Measured: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo the same sequence of study phases: pre-durian, durian consumption, and post-durian.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697612
- Sponsor's protocol ID
- DURIOME-T2D-01
- Other IDs
- 2025-1745
- Acronym
- DURIOME-T2D
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with the institution's policy. Additional research sharing agreement would be needed
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durian Consumption on Human Microbiome and Metabolome in Adults With Type 2 Diabetes Mellitus (DURIOME-T2D)
- ClinicalTrials.gov ID
- NCT07697612
- Acronym / sponsor ID
- DURIOME-T2D / DURIOME-T2D-01
- Conditions
- Type 2 Diabetes
- Keywords
- Durian, Gut Microbiome, Metabolome, Continuous Glucose Monitoring, Precision Nutrition, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (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 single-arm clinical trial investigates the effects of daily durian consumption on the gut microbiome, host metabolome, and glucose metrics in adults with type 2 diabetes mellitus (T2DM). Forty adults with T2DM will undergo a pre-durian phase, a durian consumption phase, and a post-durian phase, each lasting 10 to 14 days. Participants will attend five visits at Singapore General Hospital for clinical assessments, continuous glucose monitoring, fasting blood collection, stool sample collection, and dietary and stool record submission. The study aims to determine whether durian consumption alters microbiome and metabolomic profiles and whether it affects glycemic measures in adults with T2DM.
Detailed description
Durian is a widely consumed tropical fruit with high fiber content and multiple bioactive compounds, including phenolics, flavonoids, carotenoids, and volatile sulfur compounds. Although animal and limited human studies suggest possible metabolic effects, the impact of durian consumption on gut microbiota and host metabolomic profiles in adults with type 2 diabetes mellitus remains unclear. This single-arm interventional study will enroll 40 adults with T2DM at Singapore General Hospital. Participants will complete five study visits over approximately 1.5 to 3 months. After screening, eligible participants will enter a pre-durian phase, a durian phase, and a post-durian phase, each lasting 10 to 14 days. During the durian phase, participants will consume 100 g of durian on Day 1 and 200 g daily from Day 2 onward for 10 to 14 days. Continuous glucose monitoring will be performed across study phases. Blood samples will be analyzed for clinical laboratory parameters, inflammatory markers, metabolomics, and genetic/epigenetic analyses. Stool samples will undergo metagenomic sequencing and metabolomic analysis. The study hypothesis is that durian consumption will result in significant changes in the gut microbiome and metabolome of individuals with T2DM without adversely affecting gluometric measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo the same sequence of study phases: pre-durian, durian consumption, and post-durian.
| Arm | Type | Receives |
|---|---|---|
| Durian pulp | Experimental | Dietary Supplement: Durian pulpAdults with type 2 diabetes mellitus undergo a pre-durian observation phase, followed by daily durian consumption for 10 to 14 days, then a post-durian observation phase. All participants receive the same intervention and study procedures. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 to 70 years.
- Diagnosis of type 2 diabetes mellitus.
- Agrees to consume durian for 2 weeks.
- Body mass index 25 to 40 kg/m².
Key exclusion criteria (20 listed)
- Known or suspected intolerance or allergy to durian.
- Known skin reaction to adhesives used in a continuous glucose sensor.
- Uncontrolled diabetes (HbA1c greater than 8.5%).
- Severe hypertriglyceridemia (triglycerides greater than 4.5 mmol/L).
- Smoking.
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 |
|---|---|---|
| Durian pulpFresh durian pulp supplied by the study team. Participants consume 100 g on Day 1, then 200 g daily from Day 2 onward during the durian phase for 10 to 14 days. Participants record the timing and amount consumed each day. | Dietary supplement | Durian pulp |
Primary outcome
Change in gut microbiome composition following durian consumption
Time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Gut microbiome composition will be assessed from stool samples using comprehensive metagenomic sequencing, comparing pre-durian, durian, and post-durian phases.
Change in plasma metabolomic profile following durian consumption
Time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Plasma metabolomic changes will be assessed using mass spectrometry-based multi-omics profiling across study phases.
Change in glucose metrics during and after durian consumption
Time frame: During pre-durian, durian, and post-durian phases, each approximately 10 to 14 days
Continuous glucose monitoring data will be used to evaluate interstitial glucose patterns and gluometric parameters across study phases.
3 secondary outcomes
Change in fasting plasma glucose
Time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in fasting insulin
Time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Change in lipid profile
Time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No. To comply with the institution's policy. Additional research sharing agreement would be needed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Durian pulp in people with Type 2 Diabetes, run by Singapore General Hospital 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 4 inclusion and 20 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Chang Tan, MD, PhD (+65-6222 3322, tan.hong.chang@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome composition following durian consumption (time frame: Baseline to end of durian phase, approximately 10 to 14 days; and through post-durian phase, approximately 20 to 28 days from baseline phase start). The study lists 3 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 13 Jul 2026.