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Предстои набиране Фаза 2 NCT07457723

Gut Microbiome and Metabolic Health Study

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Healthy Volunteers

Спонсор: RDC Clinical Pty Ltd

Налично на: БГ
Обобщение
The goal of this clinical trial is to assess whether TRPTI (oleoylethanolamide) can reduce plasma imidazole propionate levels and improve insulin sensitivity and metabolic health in healthy adults aged 18 years and above with BMI 18.5-29.9 kg/m². The main question it aims to answer is does TRPTI reduce plasma imidazole propionate (a gut microbiota-derived metabolite linked to insulin resistance)? Researchers will compare TRPTI 150 mg, TRPTI 300 mg, and placebo in a parallel design to see if TRPTI reduces imidazole propionate levels and improves metabolic health markers compared to placebo. Participants will: * Take 2 capsules of their assigned study product daily for 4 consecutive weeks * Attend 2 clinic visits (at baseline and week 4)
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 * Stable diet and lifestyle for at least 4 weeks prior * Females using a prescribed form of birth control (e.g. oral contraceptive) 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 gastrointestinal disorders (IBD, IBS, celiac disease, etc.) * Use of antibiotics within 8 weeks prior to study entry * Regular use of medications that significantly affect gut microbiome (PPIs, laxatives, antacids) * Use of probiotics, prebiotics, or symbiotic within 4 weeks prior to study entry * 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 4 weeksb prior to study entry * 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 * History of infection in the month prior to the study
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
NCT07457723
Източник
anzctr
Запитване за медицински туризъм

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