Effects of Cocoa Procyanidins on Vascular Function

June 21, 2016 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
  • >18 years, <35 years

Exclusion Criteria:

  • cardiovascular disease
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • C-reactive protein > 1 mg/dl
  • malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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: Flavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
ACTIVE_COMPARATOR: Procyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing 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)
PLACEBO_COMPARATOR: Flavanols and procyanidins deprived supplement
Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change form Baseline Endothelial function at 1 month
Time Frame: Baseline and 1 month
Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month
Baseline and 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma flavanol metabolites
Time Frame: Baseline and 1 month
Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption
Baseline and 1 month
Urinary flavanol metabolites
Time Frame: Baseline and 1 month
Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Baseline and 1 month
Urinary valerolactone metabolites
Time Frame: Baseline and 1 month
Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Baseline and 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
high density lipoproteins (HDL)
Time Frame: Baseline and 1 month
measured on baseline and after 1 month
Baseline and 1 month
low density lipoproteins (LDL)
Time Frame: Baseline and 1 month
measured on baseline and after 1 month
Baseline and 1 month
triglyceride
Time Frame: Baseline and 1 month
measured on baseline and after 1 month
Baseline and 1 month
Pulse wave velocity
Time Frame: Baseline and 1 month
Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month.
Baseline and 1 month
Blood pressure
Time Frame: Baseline and 1 month
automatical measurements on baseline 2 hours postconsumption and on 1 month
Baseline and 1 month
cholesterol
Time Frame: Baseline and 1 month
measured on baseline and after 1 month
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cocoa procyanidins
  • 12-018 (CTSU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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