Age-dependent Effects of Flavanols on Vascular Status

December 14, 2014 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 1

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
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Division of Cardiology, Pulmonology and Vascular Medicine

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male participants between 18-35 years
  • healthy male participants between 50-80 years

Exclusion Criteria:

  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP > 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: flavanol rich intervention
flavanol rich drink
Dietary supplement: Flavanol rich intervention
Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks
Placebo Comparator: flavanol free intervention
flavanol free drink
Dietary supplement: Flavanol free control
Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial function
Time Frame: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14
Flow mediated dilatation (FMD)
change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma flavanol metabolites
Time Frame: analysis of metabolites between first treatment at day 0 and after last treatment at day 14
Measured by HPLC
analysis of metabolites between first treatment at day 0 and after last treatment at day 14
Ambulatory blood pressure
Time Frame: blood pressure at day 0 and at day 14
automatical measurements
blood pressure at day 0 and at day 14
Pulse wave velocity
Time Frame: 14 days
Measured by SphygmoCor
14 days
Microvascular function
Time Frame: 14 days
Measured by Laserdoppler perfusion imaging (LDPI)
14 days
Augmentation index
Time Frame: 14 days
Measured by SphygmoCor
14 days
Heart rate
Time Frame: 14 days
Measured by ECG
14 days
Erythrocyte deformability
Time Frame: 14 days
Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)
14 days
NO bioavailability
Time Frame: 14 days
Measured by CLD
14 days

Collaborators and Investigators

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

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

University of Reading

Investigators

  • Principal Investigator: Christian Heiss, MD, Division of Cardiology, Pulmonology and Vascular Medicine
  • Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonology and Vascular Medicine

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

November 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGE-111-CH
  • FLA-111-CH (Other Identifier: Flaviola)

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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