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NOT YET RECRUITING
NCT07457723
PHASE2

Gut Microbiome and Metabolic Health Study

Sponsor: RDC Clinical Pty Ltd

View on ClinicalTrials.gov

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)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-03

Completion Date

2027-03

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

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

Locations (1)

RDC Clinical

Brisbane, Queensland, Australia