Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
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
- 是
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
Klinik für Kardiologie, Pneumologie und Angiologie
Division of Cardiology, Pulmonary Diseases, Vascular Medicine
Heinrich-Heine University, Duesseldorf
