Skip to main content
OpenTrials
Completed

NCT Number: NCT07412730

Glucose Tolerance Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

RDC Clinical

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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
  • 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

Treatment and study plan

TRPTI 150mg

Dietary Supplement

Single dose of 150mg TRPTI will be orally administered.

Other names: Oleoylethanolamide

TRPTI 300mg

Dietary Supplement

Single dose of 300mg TRPTI will be orally administered.

Other names: Oleoylethanolamide

Placebo

Other

Single dose of placebo will be orally administered.

Other names: microcrystalline cellulose

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. Insulin Response - AUC

    Time frame: 0 to 120 minutes

    Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load

  2. Insulin Response - Peak insulin response

    Time frame: 0 to 120 minutes

    Peak insulin response: Maximum insulin concentration achieved during the test period

  3. Insulin Response - HOMA-IR

    Time frame: 0 minutes

    HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin.

Other outcomes

  1. Safety and Tolerability: AEs

    Time frame: Baseline to 3 hours

    Adverse events: Any untoward medical occurrences during the study period

  2. Safety and Tolerability - Blood pressure

    Time frame: Baseline to 3 hours

    Vital signs: Blood pressure at the start and end of each visit

  3. Safety and Tolerability - Heart rate

    Time frame: Baseline to 3 hours

    Vital signs: Heart rate at the start and end of each visit

  4. Safety and Tolerability - GIT Tolerance

    Time frame: Baseline to 3 hours

    GIT tolerance: Gastrointestinal Tolerance questionnaire assessing nausea, bloating, discomfort etc.

  5. Anthropometry - Weight

    Time frame: Baseline to week 3

    Weight at each visit

  6. Anthropometry - BMI

    Time frame: Baseline to week 3

    BMI at each visit

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Collaborators

  • Gencor Pacific Limited, Hong Kong

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled Crossover Study to Assess the Effect of TRPTI (Oleoylethanolamide) on Glucose Tolerance in Healthy Adults

Acronym: OEAGTT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.