Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Endothelial function
研究概览
简要总结
Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male, age 35-60 years, healthy
- •female, age 35-60 years, healthy
排除标准
- •diabetes mellitus, acute inflammation, arrhythmia, active malignancy, terminal renal failure, signs, symptoms or medication indicative of manifest cardiovascular disease (CAD, PAD, CVD)
结局指标
主要结局
Endothelial function
时间窗: Time points: day 0 [baseline], and day 30 each 0 and 2h.
次要结局
- Plasma lipids(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
- Blood pressure(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
- Glucose(Time points: day 0 [baseline], and day 30 each 0 and 2h.)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
PD Dr. med. Christian Heiss
Heinrich-Heine University, Duesseldorf
