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临床试验/NCT02728466
NCT02728466已完成不适用

Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年10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
45
试验地点
2
主要终点
Change form Baseline Endothelial function at 1 month

研究概览

简要总结

There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites & metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
  • >18 years, <35 years

排除标准

  • cardiovascular disease
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • C-reactive protein > 1 mg/dl
  • malignant disease

结局指标

主要结局

Change form Baseline Endothelial function at 1 month

时间窗: Baseline and 1 month

Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month

次要结局

  • Urinary valerolactone metabolites(Baseline and 1 month)
  • Plasma flavanol metabolites(Baseline and 1 month)
  • Urinary flavanol metabolites(Baseline and 1 month)

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

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Heinrich-Heine University, Duesseldorf

研究点 (2)

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Effects of Cocoa Procyanidins on Vascular Function | 临床试验