Glucose Tolerance Study (OEAGTT)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Glucose Tolerance
• Intervention / Treatment: Dietary supplement: TRPTI 150mg; Dietary supplement: TRPTI 300mg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRPTI 150mg; Single dose of 150mg TRPTI will be administered orally.	Dietary supplement: TRPTI 150mg; Single dose of 150mg TRPTI will be orally administered.; Other Names: Oleoylethanolamide
Experimental: TRPTI 300mg; Single dose of 300mg TRPTI will be administered orally.	Dietary supplement: TRPTI 300mg; Single dose of 300mg TRPTI will be orally administered.; Other Names: Oleoylethanolamide
Placebo Comparator: Placebo; Single dose of placebo will be administered orally.	Other: Placebo; Single dose of placebo will be orally administered.; Other Names: microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	0 to 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Response - AUC	Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load	0 to 120 minutes
Insulin Response - Peak insulin response	Peak insulin response: Maximum insulin concentration achieved during the test period	0 to 120 minutes
Insulin Response - HOMA-IR	HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin.	0 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability: AEs	Adverse events: Any untoward medical occurrences during the study period	Baseline to 3 hours
Safety and Tolerability - Blood pressure	Vital signs: Blood pressure at the start and end of each visit	Baseline to 3 hours
Safety and Tolerability - Heart rate	Vital signs: Heart rate at the start and end of each visit	Baseline to 3 hours
Safety and Tolerability - GIT Tolerance	GIT tolerance: Gastrointestinal Tolerance questionnaire assessing nausea, bloating, discomfort etc.	Baseline to 3 hours
Anthropometry - Weight	Weight at each visit	Baseline to week 3
Anthropometry - BMI	BMI at each visit	Baseline to week 3

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Collaborators: Gencor Pacific Limited, Hong Kong
• Investigators: Study Director: RV Venkatesh, Gencor Pacific

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Actual): April 2, 2026
• Study Completion (Actual): April 2, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: microcrystalline cellulose; oleoylethanolamide
• Other Study ID Numbers: OEAGTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No