A Phase 2 interventional study of TRPTI 300mg and Placebo in Healthy Volunteers, sponsored by RDC Clinical Pty Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by RDC Clinical Pty Ltd · Phase 2, Interventional, and Treatment
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:
Exclusion Criteria:
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 0mg.
Other: Placebo
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg
Also known as: Oleoylethanolamide
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg
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
Time frame: Baseline to week 8
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to week 8
Insulin Sensitivity and Metabolic Health: Homocysteine
Homocysteine
Time frame: Baseline to week 8
Safety and Tolerability - Adverse events
Adverse events: Any untoward medical occurrences during the study period
Time frame: Baseline to week 8
Safety and Tolerability - Blood pressure
Safety and tolerability, vital signs - blood pressure
Time frame: Baseline to week 8
Safety and Tolerability - Heart Rate
Safety and tolerability, vital signs - heart rate
Time frame: 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.
Time frame: 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.
Time frame: Baseline to week 8
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.
Time frame: Screening to week 8
Exploratory: Longevity markers
Changes over 8 weeks in longevity markers - Sirtuins (SIRTs)
Time frame: Baseline to week 8
Exploratory: Methylation status
Changes over 8 weeks in methylation status
Time frame: Baseline to week 8
Exploratory: Phenotypic clock
Changes in 8 weeks in phenotypic clock
Time frame: Baseline to week 8
Exploratory: High-sensitivity C-reactive protein
Changes over 8 weeks in High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline to week 8
Exploratory: Full Blood count
Changes over 8 weeks in Full blood count
Time frame: Baseline to week 8
Exploratory: Nicotinamide adenine dinucleotide
Changes over 8 weeks in Nicotinamide adenine dinucleotide (NAD+)
Time frame: Baseline to week 8
Exploratory: reduced nicotinamide adenine dinucleotide
Changes over 8 weeks in reduced nicotinamide adenine dinucleotide (NADH)
Time frame: Baseline to week 8
Exploratory: Apolipoprotein B (ApoB)
Changes over 8 weeks in Apolipoprotein B (ApoB)
Time frame: Baseline to week 8
Exploratory: Interleukin (IL)-6
Changes over 8 weeks in Interleukin (IL)-6
Time frame: Baseline to week 8
Exploratory: Adiponectin
Changes over 8 weeks in Adiponectin
Time frame: Baseline to week 8
Exploratory: Genome-wide DNA methylation
Changes over 8 weeks in Genome-wide DNA methylation (CpG methylation patterns and epigenetic clock)
Time frame: Baseline to week 8
Exploratory: Flow Cytometry
Change in exploratory cellular biomarkers associated with autophagy, cellular signaling, senescence and DNA damage in PBMCs
Time frame: Baseline to week 8.
Plan to share: Undecided
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RDC Clinical Pty Ltd