Glucose Tolerance Study

NCT07412730 | Completed Phase 2

• 1 other identifier: OEAGTT
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Insulin Response - AUC

  0 to 120 minutes

• Insulin Response - Peak insulin response

  0 to 120 minutes

• Insulin Response - HOMA-IR

  0 minutes

Other Outcomes (6)

• Safety and Tolerability: AEs

  Baseline to 3 hours

• Safety and Tolerability - Blood pressure

  Baseline to 3 hours

• Safety and Tolerability - Heart rate

  Baseline to 3 hours

Study Arms (3)

TRPTI 150mg

EXPERIMENTAL

Single dose of 150mg TRPTI will be administered orally.

Dietary Supplement: TRPTI 150mg

TRPTI 300mg

EXPERIMENTAL

Single dose of 300mg TRPTI will be administered orally.

Dietary Supplement: TRPTI 300mg

Placebo

PLACEBO COMPARATOR

Single dose of placebo will be administered orally.

Other: Placebo

Interventions

TRPTI 150mg DIETARY_SUPPLEMENT

Single dose of 150mg TRPTI will be orally administered.

Also known as: Oleoylethanolamide

TRPTI 150mg

TRPTI 300mg DIETARY_SUPPLEMENT

Single dose of 300mg TRPTI will be orally administered.

Also known as: Oleoylethanolamide

TRPTI 300mg

Placebo OTHER

Single dose of placebo will be orally administered.

Also known as: microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead
• Gencor Pacific Limited, Hong Kong: collaborator

Study Sites (1)

RDC Clinical

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

oleoylethanolamide; microcrystalline cellulose

Study Officials

• RV Venkatesh

  Gencor Pacific

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomised, placebo-controlled crossover study with 3 treatment arms

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: March 11, 2026
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-02

Locations

AU (1)