Effects of Cocoa Procyanidins on Vascular Function
- Conditions
- Healthy
- Registration Number
- NCT02728466
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 45
- healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
- >18 years, <35 years
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- C-reactive protein > 1 mg/dl
- malignant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change form Baseline Endothelial function at 1 month Baseline and 1 month Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month
- Secondary Outcome Measures
Name Time Method Urinary valerolactone metabolites Baseline and 1 month Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Plasma flavanol metabolites Baseline and 1 month Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption
Urinary flavanol metabolites Baseline and 1 month Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Trial Locations
- Locations (1)
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
🇩🇪Duesseldorf, Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf🇩🇪Duesseldorf, Germany