Healthy VolunteersPhase 2IMPTRPNCT07457723
Gut Microbiome and Metabolic Health Study
A Phase 2 study testing TRPTI 300mg in people with Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TRPTI 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
RDC Clinical
Brisbane, Queensland, 4006
Amanda Rao, PhD, +61 (07) 3102 4486, research@rdcglobal.com.au
Amanda Rao, PhD
About this study
Official 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
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.
Read more
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)
- Conditions
- Healthy Volunteers
- Being tested
- TRPTI 300mg, Placebo
- Keywords
- Gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPTI 300mgDietary supplement
Also called Oleoylethanolamide
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg
PlaceboOther
Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg
| Study group | Role | What they receive |
|---|---|---|
| TRPTI 300mg | Experimental | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg. Receives: Dietary Supplement: TRPTI 300mg |
| Placebo | Placebo comparator | Participants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to week 8
Secondary outcomes (13)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to week 8
Insulin Sensitivity and Metabolic Health: Homocysteine
Homocysteine
Measured: Baseline to week 8
Safety and Tolerability - Adverse events
Adverse events: Any untoward medical occurrences during the study period
Measured: Baseline to week 8
Safety and Tolerability - Blood pressure
Safety and tolerability, vital signs - blood pressure
Measured: Baseline to week 8
Safety and Tolerability - Heart Rate
Safety and tolerability, vital signs - heart rate
Measured: 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.
Measured: 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.
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start8 Jul 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Responsible party
- Sponsor
- Investigators
- RV Venkatesh, Study director, Gencor Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457723
- Sponsor's protocol ID
- IMPTRP
- Acronym
- IMPTRP
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07457723
- Acronym / sponsor ID
- IMPTRP / IMPTRP
- Conditions
- Healthy Volunteers
- Keywords
- Gut microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomised, placebo-controlled parallel study with 2 treatment groups
| Arm | Type | Receives |
|---|---|---|
| TRPTI 300mg | Experimental | Dietary Supplement: TRPTI 300mgParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRPTI 300mgAlso: OleoylethanolamideParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 300mg | Dietary supplement | TRPTI 300mg |
| PlaceboParticipants will take two capsules daily, for 28 consecutive days. Their daily dose of TRPTI will be 0mg | Other | Placebo |
Primary outcome
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
13 secondary outcomes
Gut Microbiome Composition
Time frame: Baseline to week 8
Histidine Metabolic Pathway - Histidine
Time frame: Baseline to week 8
Histidine Metabolic Pathway - Histamine
Time frame: Baseline to week 8
Histidine Metabolic Pathway - Urocanic acid
Time frame: Baseline to week 8
Insulin Sensitivity and Metabolic Health: HOMA-IR
Time frame: Baseline to week 8
Insulin Sensitivity and Metabolic Health: HOMA2
Time frame: Baseline to week 8
Insulin Sensitivity and Metabolic Health: Lipid profile
Time frame: Baseline to week 8
Insulin Sensitivity and Metabolic Health: Homocysteine
Time frame: Baseline to week 8
Safety and Tolerability - Adverse events
Time frame: Baseline to week 8
Safety and Tolerability - Blood pressure
Time frame: Baseline to week 8
Safety and Tolerability - Heart Rate
Time frame: Baseline to week 8
Safety and Tolerability - E/LFT (electrolytes)
Time frame: Baseline to week 8
Safety and Tolerability - E/LFT (Liver Function test)
Time frame: Baseline to week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
RV Venkatesh study director
Gencor Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRPTI 300mg in people with Healthy Volunteers, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Rao (+61 (0) 7 3102 4486, research@rdcglobal.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imidazole Propionate (ImP) (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.