Age-dependent Effects of Flavanols on Vascular Status

This study is currently recruiting participants.
Verified March 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Collaborator:
University of Reading
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01639781
First received: June 6, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by HPLC

  • Ambulatory blood pressure [ Time Frame: blood pressure at day 0 and at day 14 ] [ Designated as safety issue: No ]
    automatical measurements

  • Pulse wave velocity [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by SphygmoCor

  • Microvascular function [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by Laserdoppler perfusion imaging (LDPI)

  • Augmentation index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by SphygmoCor

  • Heart rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by ECG

  • Erythrocyte deformability [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)

  • NO bioavailability [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Measured by CLD


Estimated Enrollment: 44
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639781

Contacts
Contact: Christian Heiss, MD 02118118800 Christian.Heiss@med.uni-duesseldorf.de
Contact: Roberto Sansone, MD 015782190882 Roberto.Sansone@med.uni-duesseldorf.de

Locations
Germany
Division of Cardiology, Pulmonology and Vascular Medicine Recruiting
Duesseldorf, NRW, Germany, 40225
Principal Investigator: Christian Heiss, MD         
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

No publications provided

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
Study First Received: June 6, 2012
Last Updated: March 4, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Heinrich-Heine University, Duesseldorf:
flavanols
age related cardiovascular effects

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014