Healthy VolunteersPhase 2OEAGTTNCT07412730
Glucose Tolerance Study
A Phase 2 study testing TRPTI 150mg and TRPTI 300mg in people with Healthy Volunteers and Glucose Tolerance, 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 improve glucose tolerance in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main questions it aims to answer are: Does TRPTI improve glucose tolerance as measured by glucose area under the curve (AUC) from 0-120… 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, Glucose Tolerance
- What is being tested?
- TRPTI 150mg and TRPTI 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Mar 2026to 2 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18.5-29.9 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
- Females using a prescribed form of birth control (e.g. oral contraceptive)
- Able to attend the clinic on all required days.
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 diabetes (Type I or II), or impaired glucose tolerance
- Fasting glucose ≥5.9 mmol/L or known random glucose ≥11.1 mmol/L
- Use of medications that affect glucose metabolism (e.g., corticosteroids, beta-blockers, diuretics).
- 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
Show all 13Show fewer
- 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 the past 4 weeks
- 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
- Recent infection or trauma in the month prior to the study or on the days of the clinic visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Crossover Study to Assess the Effect of TRPTI (Oleoylethanolamide) on Glucose Tolerance in Healthy Adults
The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can improve glucose tolerance in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main questions it aims to answer are:
- Does TRPTI improve glucose tolerance as measured by glucose area under the curve (AUC) from 0-120 minutes following a glucose load?
- Does TRPTI reduce peak glucose response and alter the time to peak glucose concentration?
- Are there dose-dependent effects between 150 mg and 300 mg doses of TRPTI?
Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a crossover design to see if TRPTI improves glucose metabolism and insulin sensitivity compared to placebo. Participants will complete 3 clinic visits (each lasting approximately 4 hours) with a minimum 6-day washout period between visits.
- Conditions
- Healthy Volunteers, Glucose Tolerance
- Being tested
- TRPTI 150mg, TRPTI 300mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPTI 150mgDietary supplement
Also called Oleoylethanolamide
Single dose of 150mg TRPTI will be orally administered.
TRPTI 300mgDietary supplement
Also called Oleoylethanolamide
Single dose of 300mg TRPTI will be orally administered.
PlaceboOther
Also called microcrystalline cellulose
Single dose of placebo will be orally administered.
| Study group | Role | What they receive |
|---|---|---|
| TRPTI 150mg | Experimental | Single dose of 150mg TRPTI will be administered orally. Receives: Dietary Supplement: TRPTI 150mg |
| TRPTI 300mg | Experimental | Single dose of 300mg TRPTI will be administered orally. Receives: Dietary Supplement: TRPTI 300mg |
| Placebo | Placebo comparator | Single dose of placebo will be administered orally. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance - AUC
Change from baseline to the end of the study period in Glucose AUC (0-120 min): Area under the curve for glucose concentration from 0-120 minutes post-glucose load
Measured: 0 to 120mins
Glucose - Peak glucose response
Change from baseline to the end of the study period in Peak glucose response - Maximum glucose concentration achieved during the test period.
Measured: 0 to 120minutes
Glucose Tolerance - Time to Peak Glucose
Change from baseline to the end of the study period in Time to peak glucose - Time point at which maximum glucose concentration occurs.
Measured: 0 to 120 minutes
Secondary outcomes (3)
Insulin Response - AUC
Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load
Measured: 0 to 120 minutes
Insulin Response - Peak insulin response
Peak insulin response: Maximum insulin concentration achieved during the test period
Measured: 0 to 120 minutes
Insulin Response - HOMA-IR
HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin.
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Mar 2026
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
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.
- 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
- Crossover
- Model description
- Double-blind, randomised, placebo-controlled crossover study with 3 treatment arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
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
- NCT07412730
- Sponsor's protocol ID
- OEAGTT
- Acronym
- OEAGTT
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Crossover Study to Assess the Effect of TRPTI (Oleoylethanolamide) on Glucose Tolerance in Healthy Adults
- ClinicalTrials.gov ID
- NCT07412730
- Acronym / sponsor ID
- OEAGTT / OEAGTT
- Conditions
- Healthy Volunteers, Glucose Tolerance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Gencor Pacific Limited, Hong Kong
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 17 Feb 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 improve glucose tolerance in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main questions it aims to answer are:
- Does TRPTI improve glucose tolerance as measured by glucose area under the curve (AUC) from 0-120 minutes following a glucose load?
- Does TRPTI reduce peak glucose response and alter the time to peak glucose concentration?
- Are there dose-dependent effects between 150 mg and 300 mg doses of TRPTI?
Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a crossover design to see if TRPTI improves glucose metabolism and insulin sensitivity compared to placebo. Participants will complete 3 clinic visits (each lasting approximately 4 hours) with a minimum 6-day washout period between visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomised, placebo-controlled crossover study with 3 treatment arms
| Arm | Type | Receives |
|---|---|---|
| TRPTI 150mg | Experimental | Dietary Supplement: TRPTI 150mgSingle dose of 150mg TRPTI will be administered orally. |
| TRPTI 300mg | Experimental | Dietary Supplement: TRPTI 300mgSingle dose of 300mg TRPTI will be administered orally. |
| Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo will be administered orally. |
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 18.5-29.9 kg/m2
- Able to provide informed consent
- Agree to not participate in another clinical trial while enrolled in this trial
Key exclusion criteria (13 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 diabetes (Type I or II), or impaired glucose tolerance
- Fasting glucose ≥5.9 mmol/L or known random glucose ≥11.1 mmol/L
- Use of medications that affect glucose metabolism (e.g., corticosteroids, beta-blockers, diuretics).
- Current malignancy (excluding BCC) or chemotherapy and radiotherapy treatment for malignancy within the previous 2 years
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 150mgAlso: OleoylethanolamideSingle dose of 150mg TRPTI will be orally administered. | Dietary supplement | TRPTI 150mg |
| TRPTI 300mgAlso: OleoylethanolamideSingle dose of 300mg TRPTI will be orally administered. | Dietary supplement | TRPTI 300mg |
| PlaceboAlso: microcrystalline celluloseSingle dose of placebo will be orally administered. | Other | Placebo |
Primary outcome
Glucose Tolerance - AUC
Time frame: 0 to 120mins
Change from baseline to the end of the study period in Glucose AUC (0-120 min): Area under the curve for glucose concentration from 0-120 minutes post-glucose load
Glucose - Peak glucose response
Time frame: 0 to 120minutes
Change from baseline to the end of the study period in Peak glucose response - Maximum glucose concentration achieved during the test period.
Glucose Tolerance - Time to Peak Glucose
Time frame: 0 to 120 minutes
Change from baseline to the end of the study period in Time to peak glucose - Time point at which maximum glucose concentration occurs.
3 secondary outcomes
Insulin Response - AUC
Time frame: 0 to 120 minutes
Insulin Response - Peak insulin response
Time frame: 0 to 120 minutes
Insulin Response - HOMA-IR
Time frame: 0 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 150mg and TRPTI 300mg in people with Healthy Volunteers and Glucose Tolerance, 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 13 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: finished, as of the sponsor's last update on 28 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Tolerance - AUC (time frame: 0 to 120mins). The study lists 3 primary outcomes in all. 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 28 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.