Gut Microbiome and Metabolic Health Study
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRDC Clinical Pty Ltd
About this trial
The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)?
Researchers will compare TRPTI 300 mg to placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo.
Participants will:
* Take 2 capsules of their assigned study product daily for 8 consecutive weeks * Attend 3 clinic visits (at baseline, week 4 and week 8)
Eligibility criteria
Qualifiers
Adults aged 18 years and above
Generally healthy
BMI 18.5-29.9 kg/m2
Able to provide informed consent
Disqualifiers
Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid gland dysfunction)
Known gastrointestinal disorders (IBD, IBS, celiac disease, etc.)
Use of antibiotics within 8 weeks prior to study entry
Regular use of medications that significantly affect gut microbiome (PPIs, laxatives, antacids)
Trial design
Treatments tested in this trial
- TRPTI 300mg
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
RDC Clinical Pty Ltd
Lead sponsor
Gencor Pacific Limited, Hong Kong
Collaborator
Source ClinicalTrials.gov