MedTrace Logo

Effects of Cocoa Procyanidins on Vascular Function

NCT02728466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-06-22

No results posted yet for this study

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

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Christian Heiß, MD · Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

  • Malte Kelm, Prof. MD · Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02728466 on ClinicalTrials.gov