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Clinical Trials in Australia / NCT07457723
Recruiting Phase 2

Gut Microbiome and Metabolic Health Study

NCT07457723 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2026-07-08
Last updated
2026-07-22

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

TRPTI 300mgPlacebo

TRPTI 300mg: Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg

Placebo: Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Adults aged 18 years and above * Generally healthy * BMI 24.9 - 34.9 kg/m2 * Able to provide informed consent * Agree to not participate in another clinical trial while enrolled in this trial * Agree not to change current diet and/or exercise frequency or intensity during entire study period * Stable diet and lifestyle for at least 4 weeks prior * Females using a prescribed form of birth control (e.g. oral contraceptive) Exclusion Criteria: * 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) * Use of probiotics, prebiotics, or symbiotic within 4 weeks prior to study entry * Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years * Active smokers, nicotine use, alcohol or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>14 alcoholic drinks week) * Allergic to any of the ingredients in the active or placebo formula * Consistently (3 or more days per week) taken OEA within 4 weeksb prior to study entry * Known pregnant or lactating woman * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * Participants who have participated in any other non-RDC related clinical study during the past 1 month * History of infection in the month prior to the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
RDC Clinical Brisbane Queensland Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07457723 on ClinicalTrials.gov ↗ ← All trials in Australia