Gut Microbiome and Metabolic Health Study (IMPTRP)

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: TRPTI 300mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical
      • Principal Investigator: Amanda Rao, PhD
      • Contact: Amanda Rao, PhD; Phone Number: +61 (07) 3102 4486; Email: research@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRPTI 300mg; Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg.	Dietary supplement: TRPTI 300mg; Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg; Other Names: Oleoylethanolamide
Placebo Comparator: Placebo; Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg.	Other: Placebo; Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome Composition	Gut microbiome composition and functional capacity will be assessed from stool samples using 16S rRNA gene sequencing and metagenomic sequencing. Analyses will evaluate overall microbial community structure, relative abundance of histidine-metabolising bacteria, and functional pathways related to imidazole propionate production. Measurement details: Analytical method: 16S rRNA gene sequencing and shotgun metagenomic sequencing Units: Relative abundance (%), diversity indices (unitless), and pathway abundance (relative abundance)	Baseline to week 8
Histidine Metabolic Pathway - Histidine	Histidine: Precursor amino acid for ImP synthesis. Plasma histidine concentration will be quantified as a marker of substrate availability within the histidine metabolic pathway.	Baseline to week 8
Histidine Metabolic Pathway - Histamine	Histamine: Alternative histidine metabolite. Plasma histamine concentration will be measured as an alternative downstream metabolite of histidine metabolism.	Baseline to week 8
Histidine Metabolic Pathway - Urocanic acid	Urocanic acid: Intermediate metabolite in histidine degradation pathway. Plasma urocanic acid concentration (µmol/L), an intermediate metabolite in the histidine degradation pathway, will be quantified.	Baseline to week 8
Insulin Sensitivity and Metabolic Health: HOMA-IR	Insulin sensitivity and beta-cell function will be assessed using the Homeostatic Model Assessment (HOMA). Indices will be calculated from fasting plasma glucose and fasting serum insulin concentrations. Specific indices derived: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) HOMA indices derived using the HOMA2 model calculator (Oxford Centre for Diabetes, Endocrinology and Metabolism	Baseline to week 8
Insulin Sensitivity and Metabolic Health: HOMA2	Insulin sensitivity and beta-cell function will be assessed using the Homeostatic Model Assessment (HOMA). Indices will be calculated from fasting plasma glucose and fasting serum insulin concentrations. Specific indices derived: HOMA2-%B (beta-cell function) using the HOMA2 calculator HOMA indices derived using the HOMA2 model calculator (Oxford Centre for Diabetes, Endocrinology and Metabolism	Baseline to week 8
Insulin Sensitivity and Metabolic Health: Lipid profile	Triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and HDL/LDL ratio	Baseline to week 8
Insulin Sensitivity and Metabolic Health: Homocysteine	Homocysteine	Baseline to week 8
Safety and Tolerability - Adverse events	Adverse events: Any untoward medical occurrences during the study period	Baseline to week 8
Safety and Tolerability - Blood pressure	Safety and tolerability, vital signs - blood pressure	Baseline to week 8
Safety and Tolerability - Heart Rate	Safety and tolerability, vital signs - heart rate	Baseline to week 8
Safety and Tolerability - E/LFT (electrolytes)	Safety and tolerability biomarkers - Electrolytes Tests. These analytes form part of a single standard clinical chemistry panel (E/LFT) performed as one laboratory assessment for safety monitoring rather than independent mechanistic endpoints. A comprehensive clinical chemistry panel will be used to assess E/LFTs. The panel will be performed as a single laboratory assessment using standard automated clinical chemistry methods in an accredited pathology laboratory.	Baseline to week 8
Safety and Tolerability - E/LFT (Liver Function test)	Safety and tolerability biomarkers - Liver Function Tests. These analytes form part of a single standard clinical chemistry panel (E/LFT) performed as one laboratory assessment for safety monitoring rather than independent mechanistic endpoints. A comprehensive clinical chemistry panel will be used to assess E/LFTs. The panel will be performed as a single laboratory assessment using standard automated clinical chemistry methods in an accredited pathology laboratory.	Baseline to week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other: Anthropometrics	Anthropometrics provide demographics information and context for metabolic outcomes (e.g., HOMA indices) and help interpret whether any biochemical changes could be partly explained by changes or differences in body mass over the 8-week period. Measures include Height, weight and BMI, hip and waist circumference.	Screening to week 8
Exploratory: Longevity markers	Changes over 8 weeks in longevity markers - Sirtuins (SIRTs)	Baseline to week 8
Exploratory: Methylation status	Changes over 8 weeks in methylation status	Baseline to week 8
Exploratory: Phenotypic clock	Changes in 8 weeks in phenotypic clock	Baseline to week 8
Exploratory: High-sensitivity C-reactive protein	Changes over 8 weeks in High-sensitivity C-reactive protein (hs-CRP)	Baseline to week 8
Exploratory: Full Blood count	Changes over 8 weeks in Full blood count	Baseline to week 8
Exploratory: Nicotinamide adenine dinucleotide	Changes over 8 weeks in Nicotinamide adenine dinucleotide (NAD+)	Baseline to week 8
Exploratory: reduced nicotinamide adenine dinucleotide	Changes over 8 weeks in reduced nicotinamide adenine dinucleotide (NADH)	Baseline to week 8
Exploratory: Apolipoprotein B (ApoB)	Changes over 8 weeks in Apolipoprotein B (ApoB)	Baseline to week 8
Exploratory: Interleukin (IL)-6	Changes over 8 weeks in Interleukin (IL)-6	Baseline to week 8
Exploratory: Adiponectin	Changes over 8 weeks in Adiponectin	Baseline to week 8
Exploratory: Genome-wide DNA methylation	Changes over 8 weeks in Genome-wide DNA methylation (CpG methylation patterns and epigenetic clock)	Baseline to week 8

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: Gencor Pacific Limited, Hong Kong
• Investigators: Study Director: RV Venkatesh, Gencor Pacific

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Gut microbiome
• Additional Relevant MeSH Terms: oleoylethanolamide
• Other Study ID Numbers: IMPTRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No