NCT02292576已完成不适用
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
Société des Produits Nestlé (SPN)0 个研究点目标入组 50 人开始时间: 2012年6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
- 50
- 主要终点
- Measurement of changes in SOD2 gene expression
研究概览
简要总结
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa
详细描述
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •BMI between 18.5 and 30 kg/m2
- •Sedentary to moderate physical activity habits
排除标准
- •Consumption of dietary supplements, antioxidants or anti-inflammatory medication, such as aspirin, ibuprofen, naproxen, or any medication that can affect the study outcomes
- •Actively smoking
- •Suspected abuse of alcohol or illicit drugs
- •Significant illness within two weeks prior to study start or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study
- •Subject who cannot be expected to comply with study procedures
- •Currently participating or having participated in another clinical trial during last 4 weeks prior to the beginning of this study
- •Consumption of chocolate or its derivates 24 hours before the blood sample taken
研究组 & 干预措施
Acute dose/Chronic dose
Experimental
Acute dose/Chronic dose.
干预措施: Placebo (Other)
Acute dose/Chronic dose
Experimental
Acute dose/Chronic dose.
干预措施: Cocoa Pure (Other)
Chronic dose/Acute dose
Experimental
Chronic dose/Acute dose.
干预措施: Cocoa Pure (Other)
Chronic dose/Acute dose
Experimental
Chronic dose/Acute dose.
干预措施: Placebo (Other)
结局指标
主要结局
Measurement of changes in SOD2 gene expression
时间窗: after acute dose and 4 weeks of chronic dose
次要结局
- Determination of plasma antioxidant capacity as a marker of oxidative stress(After 4 weeks of chronic dose)
- Determination of DNA methylation pattern in the chronic phase of the study(After 4 weeks of chronic dose)
- Evaluation of (-)epicatechin bioavailability in plasma(After 4 weeks of chronic dose)
研究者
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