NCT07457723

Gut Microbiome and Metabolic Health Study

A Double-blind, Randomised, Placebo-controlled Parallel Study to Assess the Effectiveness of TRPTI (Oleoylethanolamide) Compared to Placebo on Gut Microbiome and Plasma Biomarker Changes in Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: RDC Clinical Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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 150 mg, TRPTI 300 mg, and 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 4 consecutive weeks * Attend 2 clinic visits (at baseline and week 4)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TRPTI 150mg	Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 150mg.
DIETARY_SUPPLEMENT	TRPTI 300mg	Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg
OTHER	Placebo	Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Australia