Gut Microbiome and Metabolic Health Study

NCT07457723 | Not Yet Recruiting Phase 2

• 1 other identifier: IMPTRP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy Volunteers

Keywords

Gut microbiome

Outcome Measures

Primary Outcomes (1)

• Imidazole Propionate (ImP)

  Plasma ImP concentration: Primary metabolite produced by histidine-metabolizing gut bacteria, strongly associated with insulin resistance and type 2 diabetes risk Change from baseline: Reduction in ImP levels indicating improved metabolic health

  Baseline to week 8

Secondary Outcomes (13)

• Gut Microbiome Composition

  Baseline to week 8

• Histidine Metabolic Pathway - Histidine

  Baseline to week 8

• Histidine Metabolic Pathway - Histamine

  Baseline to week 8

• Histidine Metabolic Pathway - Urocanic acid

  Baseline to week 8

• Insulin Sensitivity and Metabolic Health: HOMA-IR

  Baseline to week 8

Other Outcomes (12)

• Other: Anthropometrics

  Screening to week 8

• Exploratory: Longevity markers

  Baseline to week 8

• Exploratory: Methylation status

  Baseline to week 8

Study Arms (2)

TRPTI 300mg

EXPERIMENTAL

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

Dietary Supplement: TRPTI 300mg

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

TRPTI 300mg DIETARY_SUPPLEMENT

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

Also known as: Oleoylethanolamide

TRPTI 300mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and above
• Generally healthy
• BMI 18.5-29.9 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited, Hong Kong: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

oleoylethanolamide

Study Officials

• RV Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Central Study Contacts

Amanda Rao

CONTACT

+61 (0) 7 3102 4486; research@rdcglobal.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-02

Locations

AU (1)