Durian Consumption in Adults With Type 2 Diabetes Mellitus
ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorSingapore General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Durian pulp
Dietary supplementFresh 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Durian pulpExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 start2
Change in plasma metabolomic profile following durian consumption
Plasma metabolomic changes will be assessed using mass spectrometry-based multi-omics profiling across study phases.
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 start3
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.
Time frame
During pre-durian, durian, and post-durian phases, each approximately 10 to 14 daysSecondary outcomes
1
Change in fasting plasma glucose
Fasting glucose measured from blood samples across study visits.
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 start2
Change in fasting insulin
Fasting insulin measured from blood samples across study visits.
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 start3
Change in lipid profile
Lipid panel measured from fasting blood samples across study visits.
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 startSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: