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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：EMİNE DİNÇER, Doç.Dr.
- 电话号码：90+5529446064
- 邮箱：edincer@cumhuriyet.edu.tr
研究联系人备份
- 姓名：ÖZGE AKTAŞ, Dyt
- 电话号码：90+5523405058
- 邮箱：aktsozge58@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
安慰剂比较：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Total Antioxidant Capacity (TAC)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：Baseline and Day 61
|
Change from baseline to the end of the intervention in each prespecified biochemical parameter. |
Baseline and Day 61
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in paraoksonaz-1 (PON1)
大体时间：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)
大体时间：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.
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SBF-2026-125
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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.
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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