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| Name | Class |
|---|---|
| Gencor Pacific Limited, Hong Kong | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRPTI 300mg | Experimental | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg. |
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| Placebo | Placebo Comparator | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRPTI 300mg | Dietary Supplement | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg |
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| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Rao | Contact | +61 (0) 7 3102 4486 | research@rdcglobal.com.au |
| Name | Affiliation | Role |
|---|---|---|
| RV Venkatesh | Gencor Pacific | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| C488250 | oleoylethanolamide |
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Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups
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| Placebo | Other | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg |
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| 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:
| 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:
| 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 |
| 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 |