NCT01768507已完成不适用
The Effects of the Dietary Supplement Trans-resveratrol on Heme Oxygenase-1 (HO-1) and Sirtuins Expression in PBMCs in Healthy Male Subjects: A Pilot Study.
Daniel Doberer1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The maximal HO-1 and sirtuin mRNA expression in PBMCs
研究概览
简要总结
Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to evaluate the HO-1 stimulation of resveratrol in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Male patient aged between 18 and 45 years (inclusive) at screening.
- •No clinically significant findings on the physical examination at screening.
- •Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
- •Non-smoker (for at least 1 month)
- •Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- •Negative results from urine drug screen at screening.
- •Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
排除标准
- •Known hypersensitivity to resveratrol or any excipients of the resveratrol formulation.
- •Treatment with any investigational drug within 3 weeks prior to screening.
- •History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- •History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of resveratrol.
- •Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
- •Regularly intake of resveratrol rich food
- •Positive results from the hepatitis serology at screening.
- •Positive results from the HIV serology at screening.
- •Presumed non-compliance.
- •Legal incapacity or limited legal capacity at screening.
研究组 & 干预措施
Placebo
Placebo Comparator
no medication
干预措施: Resveratrol (Dietary Supplement)
Resveratrol
Experimental
Trans-resveratrol (Resveratrol - Terraternal®): 5 g (10 capsules) as single oral dose on day 1 of the investigation period.
干预措施: Resveratrol (Dietary Supplement)
结局指标
主要结局
The maximal HO-1 and sirtuin mRNA expression in PBMCs
时间窗: 1 month
次要结局
未报告次要终点
研究者
Daniel Doberer
Investigator
Medical University of Vienna
研究点 (1)
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