BERBERINE SUPPLEMENTATIONS (Berberine)
EFFECTS OF BARBERRY (BERBERIS VULGARIS) SUPPLEMENTATIONS ON ANTIOXIDANT AND OKSIDANT CAPASITY IN HEALTHY ADULTS
This randomized, placebo-controlled interventional study aims to evaluate the effects of 60 days of supplementation with a liposomal Berberis vulgaris-based product on antioxidant status, selected biochemical parameters, body weight, body mass index (BMI), and body composition in healthy adult volunteers. The planned total enrollment is 40 participants. The intervention group will receive one 200 mg capsule daily for 60 days, subject to confirmation of the product's composition and labeling. The comparator group will receive a placebo according to the approved study protocol. Total antioxidant capacity (TAC), total oxidant status (TOS), and other prespecified outcomes will be assessed using the methods and time points defined in the protocol.
Обзор исследования
Статус
Условия
Подробное описание
At baseline, participants who meet the inclusion and exclusion criteria and provide written informed consent will undergo anthropometric measurements, including body weight, height, and body composition, at the Healthy Nutrition Counseling Unit of the Faculty of Health Sciences, Sivas Cumhuriyet University. Medical history and demographic information will also be collected using a personal information form. Blood samples will be collected at the Biochemistry Laboratory of Sivas Cumhuriyet University Hospital to assess routine biochemical parameters, including glucose, insulin, renal and liver function markers, lipid profile, electrolytes, and uric acid. Blood results will be evaluated by a study physician. During the 60-day supplementation period, participants will be contacted by telephone every 15 days. Dietary intake will be assessed using 24-hour dietary recalls, and appetite status will be evaluated using the Simplified Nutrition and Appetite Questionnaire. Adherence to the intervention will be monitored through these calls and verified at the end of the study by checking the returned supplement packages and unused capsules. At baseline and at the end of the study, blood samples will also be analyzed for total antioxidant capacity (TAC), total oxidant status (TOS), paraoxonase-1 (PON1), and arylesterase (ARE) activities. Serum samples will be separated by centrifugation and stored at -80°C until analysis. TAC and TOS will be assessed as the primary outcome measures, while PON1 and ARE activities will provide additional information on enzymatic antioxidant defense. These measurements will enable a comprehensive evaluation of the effects of Berberis vulgaris supplementation on oxidative balance and antioxidant defense.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: EMİNE DİNÇER, Doç.Dr.
- Номер телефона: 90+5529446064
- Электронная почта: edincer@cumhuriyet.edu.tr
Учебное резервное копирование контактов
- Имя: ÖZGE AKTAŞ, Dyt
- Номер телефона: 90+5523405058
- Электронная почта: aktsozge58@gmail.com
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adults aged 18-65 years.
- Individuals with a body mass index (BMI) between 18,5 and 29,99 kg/m².
- Individuals who voluntarily agree to participate in the study.
- Individuals with no known medication sensitivities.
- Individuals with no known food allergies.
- Individuals who do not use medications that may affect appetite, body weight, or related parameters.
- Individuals who do not use any dietary supplements.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Individuals who smoke.
- Individuals with any medical condition that may affect the study outcomes, including diabetes mellitus, chronic obstructive pulmonary disease (COPD), and cardiovascular diseases.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental
Lipozomal Berberis Vulgaris Supplementation. Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation. |
Participants will receive one capsule daily for 60 days. The stated capsule strength is 200 mg. The amount of Berberis vulgaris extract and/or berberine per capsule, product composition, and route of administration must be confirmed from the product documentation. |
|
Плацебо Компаратор: Placebo
Placebo Supplementation. Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol. |
Participants will receive a placebo according to the approved study protocol for 60 days. The dosage form, administration schedule, and matching characteristics will be specified based on the protocol. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Total Antioxidant Capacity (TAC)
Временное ограничение: Baseline and Day 61
|
Change in total antioxidant capacity from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61
|
|
Change in Total Oxidant Status (TOS)
Временное ограничение: Baseline and Day 61
|
Change in total oxidant status from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61
|
|
Change in Body Weight
Временное ограничение: Baseline and Day 61
|
Change in body weight from baseline to the end of the intervention, measured in kilograms. |
Baseline and Day 61
|
|
Change in Body Mass Index (BMI)
Временное ограничение: Baseline and Day 61
|
Change in body mass index from baseline to the end of the intervention, weight and height will be combined to report BMI in kg/m^2). |
Baseline and Day 61
|
|
Change in Body Composition
Временное ограничение: Baseline and Day 61
|
Change from baseline in the prespecified body composition parameters assessed using TANITA MC 780MA. |
Baseline and Day 61
|
|
Change in Biochemical Parameters
Временное ограничение: Baseline and Day 61
|
Change from baseline to the end of the intervention in each prespecified biochemical parameter. |
Baseline and Day 61
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in paraoksonaz-1 (PON1)
Временное ограничение: Baseline and Day 61.
|
Change in paraoksonaz-1 (PON1) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61.
|
|
Change in arilesteraz (ARE)
Временное ограничение: Baseline and Day 61.
|
Change in arilesteraz (ARE) from baseline to the end of the 60-day intervention, measured using enzyme-linked immunosorbent assay (ELISA) kits. |
Baseline and Day 61.
|
Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Общие публикации
- Vahedi-Mazdabadi Y, Shahinfar H, Toushih M, Shidfar F. Effects of berberine and barberry on selected inflammatory biomarkers in adults: A systematic review and dose-response meta-analysis of randomized clinical trials. Phytother Res. 2023 Dec;37(12):5541-5557. doi: 10.1002/ptr.7998. Epub 2023 Sep 7.
- Shidfar F, Ebrahimi SS, Hosseini S, Heydari I, Shidfar S, Hajhassani G. The Effects of Berberis vulgaris Fruit Extract on Serum Lipoproteins, apoB, apoA-I, Homocysteine, Glycemic Control and Total Antioxidant Capacity in Type 2 Diabetic Patients. Iran J Pharm Res. 2012 Spring;11(2):643-52.
- Shakeri F, Kiani S, Rahimi G, Boskabady MH. Anti-inflammatory, antioxidant, and immunomodulatory effects of Berberis vulgaris and its constituent berberine, experimental and clinical, a review. Phytother Res. 2024 Apr;38(4):1882-1902. doi: 10.1002/ptr.8077. Epub 2024 Feb 15.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- SBF-2026-125
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
There is no plan to make individual participant data available due to institutional data privacy regulations and conditions of the informed consent form signed by the participants.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .