NCT07457723 Gut Microbiome and Metabolic Health Study
| NCT ID | NCT07457723 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | RDC Clinical Pty Ltd |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2026-07-08 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
RV Venkatesh
STUDY DIRECTOR
Gencor Pacific
Frequently Asked Questions
Who can join the NCT07457723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07457723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07457723 currently recruiting?
Yes, NCT07457723 is actively recruiting participants. Contact the research team at research@rdcglobal.com.au for enrollment information.
Where is the NCT07457723 trial being conducted?
This trial is being conducted at Brisbane, Australia.
Who is sponsoring the NCT07457723 clinical trial?
NCT07457723 is sponsored by RDC Clinical Pty Ltd. The principal investigator is RV Venkatesh at Gencor Pacific. The trial plans to enroll 90 participants.