Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTFlavanol and procyanidin supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
DIETARY_SUPPLEMENTProcyanidin-containing supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
DIETARY_SUPPLEMENTcontrol supplement deprived of flavanols and procyanidinsPlacebo 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.