Trials / Completed
CompletedNCT02728466
Effects of Cocoa Procyanidins on Vascular Function
Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Heinrich-Heine University, Duesseldorf · Academic / Other
- Sex
- Male
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Flavanol and procyanidin supplement | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers) |
| DIETARY_SUPPLEMENT | Procyanidin-containing supplement | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) |
| DIETARY_SUPPLEMENT | control supplement deprived of flavanols and procyanidins | Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2016-04-05
- Last updated
- 2016-06-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02728466. Inclusion in this directory is not an endorsement.