Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Healthy Volunteers
Glucose Tolerance
Спонсор: RDC Clinical Pty Ltd
Налично на:
БГ
Обобщение
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.
Кой може да участва
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 ≥5.6 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