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Official title Gut Microbiome and Metabolic Health Study
ClinicalTrials.gov ID: NCT07457723
What this study is testing
- What it's testing
- 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)?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Unstable or serious illness (e.g. Serious mood disorders, neurological disorders such as MS, kidney disease, liver disease, heart conditions, thyroid...
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.