Glucose Tolerance, Healthy Volunteers
Conditions
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.
Interventions
DIETARY_SUPPLEMENTTRPTI 150mg
Single dose of 150mg TRPTI will be orally administered.
DIETARY_SUPPLEMENTTRPTI 300mg
Single dose of 300mg TRPTI will be orally administered.
OTHERPlacebo
Single dose of placebo will be orally administered.
Sponsors
RDC Clinical Pty Ltd
Gencor Pacific Limited, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blind, randomised, placebo-controlled crossover study with 3 treatment arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Tolerance - AUC | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Insulin Response - AUC | 0 to 120 minutes | Insulin AUC (0-120 min): Area under the curve for insulin concentration from 0-120 minutes post-glucose load |
| Insulin Response - Peak insulin response | 0 to 120 minutes | Peak insulin response: Maximum insulin concentration achieved during the test period |
| Insulin Response - HOMA-IR | 0 minutes | HOMA-IR: Homeostatic Model Assessment of Insulin Resistance calculated from fasting glucose and insulin. |
Countries
Australia
Contacts
STUDY_DIRECTORRV Venkatesh
Gencor Pacific
Outcome results
None listed