Gut microbiome and metabolic health test in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, parallel-group Phase 2 trial compares TRPTI 300 mg taken twice daily for 8 weeks against placebo in generally healthy adults aged 18 and older with BMI between 24.9 and 34.9 kg/m2. Participants will take 2 capsules daily and visit the clinic at baseline, week 4, and week 8 to monitor metabolic markers and gut microbiome-related parameters. The main goal is to see if TRPTI reduces plasma imidazole propionate and improves insulin sensitivity and metabolic health versus placebo. Exclusion criteria filter out individuals with significant illnesses, recent antibiotic use, or microbiome-altering medications. The study is led by RDC Clinical Pty Ltd with collaboration from Gencor Pacific Limited, conducted at RDC Clinical in Brisbane, Australia.

Why it matters

Who can join: the full rules

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

Where it's running

• RDC Clinical
  Brisbane, Queensland, Australia Recruiting

Study contacts

• Study coordinator: Amanda Rao
• Email: research@rdcglobal.com.au
• Phone: +61 (0) 7 3102 4486

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.