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临床试验/NCT01799005
NCT01799005已完成不适用

Impact of Dietary Flavanols on Vascular Health in a General Population of Healthy Middle-aged Europeans: a Randomized Controlled Study

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月1日最近更新:
适应症

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

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

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

PD Dr. med. Christian Heiss

Heinrich-Heine University, Duesseldorf

研究点 (2)

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