Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Gene expression changes in PBMCs (using a microarray)
研究概览
简要总结
It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.
详细描述
This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.
排除标准
- •Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
- •Regular medication
- •Consumption of medication during the last week
- •Following a weight-loss diet
- •Vegetarians
- •Abnormal glucose levels
- •Cardiovascular disease
- •Gastrointestinal disease
结局指标
主要结局
Gene expression changes in PBMCs (using a microarray)
时间窗: 0-6 hours
次要结局
- Blood pressure(0-2-3-6 hours)
- Endothelial function (assessed by ischemic reactive hyperemia)(0-2-3-6 hours)
- Plasma levels of procyanidins metabolites(0-6 hours)