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
Qualifiers
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
Treatments tested in this trial
- Durian pulp
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov