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Предстои набиране Фаза 2 NCT07412730

Glucose Tolerance Study

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
Места на провеждане 1
Австралия (1)
RDC Clinical
Brisbane , Queensland
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.03.2026
Крайна дата
01.03.2027
Регистрационен номер
NCT07412730
Източник
anzctr
Запитване за медицински туризъм

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