Clinical Study of Resveratrol on Drug and Carcinogen Metabolizing Enzymes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Modulation of CYP enzyme activities
研究概览
简要总结
Resveratrol may prevent cancer in healthy people. Studying samples of blood and urine in the laboratory from participants who are taking resveratrol may help doctors learn more about how this drug is used by the body. This phase I trial is studying the side effects of resveratrol and to see how it works in healthy adult participants.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of resveratrol on human cytochrome P450 (CYP) enzyme activity in healthy adult participants.
SECONDARY OBJECTIVES:
I. To determine the modulation effect on phase II detoxification enzymes. II. To evaluate safety in participants treated with this drug.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Participants receive oral resveratrol once daily for 4 weeks.
干预措施: resveratrol (Drug)
Arm I
Participants receive oral resveratrol once daily for 4 weeks.
干预措施: pharmacological study (Other)
Arm I
Participants receive oral resveratrol once daily for 4 weeks.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Modulation of CYP enzyme activities
时间窗: From baseline to end of resveratrol intervention
Will be assessed by a comparison of CYP enzyme activities from baseline to end of resveratrol intervention. CYP1A2, 2D6, 2C9, and 3A4 activity will be assessed by plasma paraxanthine/caffeine ratio, urinary dextromethorphan/dextrophan ratio, urinary losartan/losartan metabolite ratio, and area under the plasma buspirone concentration-time curve, respectively. The primary analysis will consist of paired t-tests of differences in log values from baseline to end of intervention (equivalent to log of the ratio).
次要结局
- Safety evaluation using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0(Up to 6 weeks)
- Changes in Phase II enzyme activity(From baseline to end of resveratrol intervention)