The Role of EGCG in Different Application Forms on Flow-mediated Dilation in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Flow-mediated dilation of the arteria brachialis
研究概览
简要总结
Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.
Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.
In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy volunteers
- •20-50 years
- •BMI < 27 kg/m2
- •Cholesterol < 240 mg/dl
排除标准
- •Diabetes mellitus
- •Hypertension
- •Conditions with impaired endothelial function
- •Regular drug use
- •Alcohol abuse
- •Regular tea drinkers
研究组 & 干预措施
Epigallocatechin-3-gallate (EGCG)
200 mg EGCG and same volume water as for tea beverage.
干预措施: EGCG (Dietary Supplement)
Green tea beverage
200 mg EGCG as green tea beverage.
干预措施: Green tea beverage (Dietary Supplement)
Placebo (Water)
Same volume water as for all intervention arms.
干预措施: Placebo (Other)
Green tea extract
200 mg EGCG as green tea extract and same volume water as for tea beverage.
干预措施: Green tea extract (Dietary Supplement)
结局指标
主要结局
Flow-mediated dilation of the arteria brachialis
时间窗: 2 hours after ingestion
Change in flow-mediated dilation (in %) of the arteria brachialis after a single dose of 200 mg EGCG either as green tea beverage, green tea extract or EGCG is assessed by vascular ultrasound.
次要结局
- Agonist-induced platelet aggregation in vitro(2 hours after ingestion)
- Determination of plasma tea polyphenol levels(2 hours after ingestion)
研究者
Mario Lorenz, PhD
PhD
Charite University, Berlin, Germany