Healthy Volunteers
Conditions
Keywords
Gut microbiome
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)
Interventions
DIETARY_SUPPLEMENTTRPTI 300mg
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg
OTHERPlacebo
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg
Sponsors
RDC Clinical Pty Ltd
Gencor Pacific Limited, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Imidazole Propionate (ImP) | 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
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome Composition | 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) |
| Histidine Metabolic Pathway - Histidine | 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. |
| Histidine Metabolic Pathway - Histamine | Baseline to week 8 | Histamine: Alternative histidine metabolite. Plasma histamine concentration will be measured as an alternative downstream metabolite of histidine metabolism. |
| Histidine Metabolic Pathway - Urocanic acid | 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. |
| Insulin Sensitivity and Metabolic Health: HOMA-IR | 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 |
| Insulin Sensitivity and Metabolic Health: HOMA2 | 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 |
| Insulin Sensitivity and Metabolic Health: Lipid profile | Baseline to week 8 | Triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and HDL/LDL ratio |
| Insulin Sensitivity and Metabolic Health: Homocysteine | Baseline to week 8 | Homocysteine |
| Safety and Tolerability - Adverse events | Baseline to week 8 | Adverse events: Any untoward medical occurrences during the study period |
| Safety and Tolerability - Blood pressure | Baseline to week 8 | Safety and tolerability, vital signs - blood pressure |
| Safety and Tolerability - Heart Rate | Baseline to week 8 | Safety and tolerability, vital signs - heart rate |
| Safety and Tolerability - E/LFT (electrolytes) | 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. |
| Safety and Tolerability - E/LFT (Liver Function test) | 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. |
Countries
Australia
Contacts
CONTACTAmanda Rao
STUDY_DIRECTORRV Venkatesh
Gencor Pacific
Outcome results
None listed