Glucose Tolerance Study

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.

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