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临床试验/NCT01308892
NCT01308892已完成不适用

Cardiovascular Health Effects of Flavanol Rich Chocolate

Wageningen University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Investigator)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 45-70 years old
  • BMI between 25 and 32 kg/m2

排除标准

  • Urine glucose concentrations outside normal ranges (> 0,25 g/l)
  • Fasting blood glucose < 7.0 mmol/L)
  • Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg
  • Blood Hb values below 8.4 mmol/L
  • Allergic to cow milk, dairy products or chocolate
  • Vegetarian
  • Tobacco smoker
  • Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

结局指标

主要结局

Blood pressure

时间窗: 0, 4wk

FMD

时间窗: 0, 4wk

PWA

时间窗: 0, 4wk

次要结局

  • leukocyte count and activation(0, 4wk)
  • PBMC gene expression(0 and 2 hrs)
  • Markers of inflammation and ED(0, 4wk)
  • Blood pressure(0 and 2h)
  • FMD(0 and 2hrs)
  • PWA(0 and 2 hrs)
  • Leukocyte count and activation(0 and 2 hrs)
  • markers of inflammation and ED(0 and 2hrs)

研究者

申办方类型
Other

研究点 (2)

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