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NCT Number: NCT07457723

Gut Microbiome and Metabolic Health Study

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)

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location status: Recruiting

Location contact

Amanda Rao, PhD

CONTACT

[email protected]

+61 (07) 3102 4486

Amanda Rao, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRPTI 300mg

Dietary Supplement

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

Other names: Oleoylethanolamide

Placebo

Other

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

Primary outcomes

  1. Imidazole Propionate (ImP)

    Time frame: Baseline to week 8

    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

Secondary outcomes

  1. Gut Microbiome Composition

    Time frame: Baseline to week 8

    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)

  2. Histidine Metabolic Pathway - Histidine

    Time frame: Baseline to week 8

    Histidine: Precursor amino acid for ImP synthesis. Plasma histidine concentration will be quantified as a marker of substrate availability within the histidine metabolic pathway.

  3. Histidine Metabolic Pathway - Histamine

    Time frame: Baseline to week 8

    Histamine: Alternative histidine metabolite. Plasma histamine concentration will be measured as an alternative downstream metabolite of histidine metabolism.

  4. Histidine Metabolic Pathway - Urocanic acid

    Time frame: Baseline to week 8

    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.

  5. Insulin Sensitivity and Metabolic Health: HOMA-IR

    Time frame: Baseline to week 8

    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

  6. Insulin Sensitivity and Metabolic Health: HOMA2

    Time frame: Baseline to week 8

    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

  7. Insulin Sensitivity and Metabolic Health: Lipid profile

    Time frame: Baseline to week 8

    Triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and HDL/LDL ratio

  8. Insulin Sensitivity and Metabolic Health: Homocysteine

    Time frame: Baseline to week 8

    Homocysteine

  9. Safety and Tolerability - Adverse events

    Time frame: Baseline to week 8

    Adverse events: Any untoward medical occurrences during the study period

  10. Safety and Tolerability - Blood pressure

    Time frame: Baseline to week 8

    Safety and tolerability, vital signs - blood pressure

  11. Safety and Tolerability - Heart Rate

    Time frame: Baseline to week 8

    Safety and tolerability, vital signs - heart rate

  12. Safety and Tolerability - E/LFT (electrolytes)

    Time frame: Baseline to week 8

    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.

  13. Safety and Tolerability - E/LFT (Liver Function test)

    Time frame: Baseline to week 8

    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.

Other outcomes

  1. Other: Anthropometrics

    Time frame: Screening to week 8

    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.

  2. Exploratory: Longevity markers

    Time frame: Baseline to week 8

    Changes over 8 weeks in longevity markers - Sirtuins (SIRTs)

  3. Exploratory: Methylation status

    Time frame: Baseline to week 8

    Changes over 8 weeks in methylation status

  4. Exploratory: Phenotypic clock

    Time frame: Baseline to week 8

    Changes in 8 weeks in phenotypic clock

  5. Exploratory: High-sensitivity C-reactive protein

    Time frame: Baseline to week 8

    Changes over 8 weeks in High-sensitivity C-reactive protein (hs-CRP)

  6. Exploratory: Full Blood count

    Time frame: Baseline to week 8

    Changes over 8 weeks in Full blood count

  7. Exploratory: Nicotinamide adenine dinucleotide

    Time frame: Baseline to week 8

    Changes over 8 weeks in Nicotinamide adenine dinucleotide (NAD+)

  8. Exploratory: reduced nicotinamide adenine dinucleotide

    Time frame: Baseline to week 8

    Changes over 8 weeks in reduced nicotinamide adenine dinucleotide (NADH)

  9. Exploratory: Apolipoprotein B (ApoB)

    Time frame: Baseline to week 8

    Changes over 8 weeks in Apolipoprotein B (ApoB)

  10. Exploratory: Interleukin (IL)-6

    Time frame: Baseline to week 8

    Changes over 8 weeks in Interleukin (IL)-6

  11. Exploratory: Adiponectin

    Time frame: Baseline to week 8

    Changes over 8 weeks in Adiponectin

  12. Exploratory: Genome-wide DNA methylation

    Time frame: Baseline to week 8

    Changes over 8 weeks in Genome-wide DNA methylation (CpG methylation patterns and epigenetic clock)

  13. Exploratory: Flow Cytometry

    Time frame: Baseline to week 8.

    Change in exploratory cellular biomarkers associated with autophagy, cellular signaling, senescence and DNA damage in PBMCs

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Rao

CONTACT

[email protected]

+61 (0) 7 3102 4486

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong

Registry information

Official study 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

Acronym: IMPTRP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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