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Gut Microbiome and Metabolic Health Study

NCT07457723 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

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 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)

Conditions

  • Healthy Volunteers

Interventions

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

Sponsors & Collaborators

  • Gencor Pacific Limited, Hong Kong

    collaborator INDUSTRY

  • RDC Clinical Pty Ltd

    lead INDUSTRY

Principal Investigators

  • RV Venkatesh · Gencor Pacific

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457723 on ClinicalTrials.gov