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Age-dependent Effects of Flavanols on Vascular Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639781
First Posted: July 13, 2012
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Reading
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Dietary Supplement: Flavanol rich intervention Dietary Supplement: Flavanol free control Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.

Further study details as provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Plasma flavanol metabolites [ Time Frame: analysis of metabolites between first treatment at day 0 and after last treatment at day 14 ]
    Measured by HPLC

  • Ambulatory blood pressure [ Time Frame: blood pressure at day 0 and at day 14 ]
    automatical measurements

  • Pulse wave velocity [ Time Frame: 14 days ]
    Measured by SphygmoCor

  • Microvascular function [ Time Frame: 14 days ]
    Measured by Laserdoppler perfusion imaging (LDPI)

  • Augmentation index [ Time Frame: 14 days ]
    Measured by SphygmoCor

  • Heart rate [ Time Frame: 14 days ]
    Measured by ECG

  • Erythrocyte deformability [ Time Frame: 14 days ]
    Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)

  • NO bioavailability [ Time Frame: 14 days ]
    Measured by CLD


Estimated Enrollment: 44
Study Start Date: November 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639781


Locations
Germany
Division of Cardiology, Pulmonology and Vascular Medicine
Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01639781     History of Changes
Other Study ID Numbers: AGE-111-CH
FLA-111-CH ( Other Identifier: Flaviola )
First Submitted: June 6, 2012
First Posted: July 13, 2012
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
flavanols
age related cardiovascular effects

Additional relevant MeSH terms:
Cardiovascular Diseases