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Recruiting NCT07457723

Gut Microbiome and Metabolic Health Study

Phase II Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRPTI 300mg, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-blind, Randomised, Placebo-controlled Parallel Study to Assess the Effectiveness of TRPTI (Oleoylethanolamide) Compared to Placebo on Gut Microbiome and Plasma Biomarker Changes in Healthy Adults

Overview

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)

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

Primary outcome measures

  • Imidazole Propionate (ImP) [Time frame: Baseline to week 8]
Secondary outcome measures (12)
  • Gut Microbiome Composition [Time frame: Baseline to week 8]
  • Histidine Metabolic Pathway - Histidine [Time frame: Baseline to week 8]
  • Histidine Metabolic Pathway - Histamine [Time frame: Baseline to week 8]
  • Histidine Metabolic Pathway - Urocanic acid [Time frame: Baseline to week 8]
  • Insulin Sensitivity and Metabolic Health: HOMA-IR [Time frame: Baseline to week 8]
  • Insulin Sensitivity and Metabolic Health: HOMA2 [Time frame: Baseline to week 8]
  • Insulin Sensitivity and Metabolic Health: Lipid profile [Time frame: Baseline to week 8]
  • Insulin Sensitivity and Metabolic Health: Homocysteine [Time frame: Baseline to week 8]
  • Safety and Tolerability - Adverse events [Time frame: Baseline to week 8]
  • Safety and Tolerability - Blood pressure [Time frame: Baseline to week 8]
  • Safety and Tolerability - Heart Rate [Time frame: Baseline to week 8]
  • Safety and Tolerability - E/LFT (electrolytes) [Time frame: Baseline to 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • RDC Clinical — Brisbane

Identifiers

NCT: NCT07457723 · IMPTRP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗