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Sex-dependent Effects of Flavanols on Vascular Status

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.
 
ClinicalTrials.gov Identifier: NCT02147223
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Study Description
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Brief Summary:
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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Dietary Supplement: Flavanol rich intervention Dietary Supplement: Flavanol free intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Flavanol rich product A
250 mg flavanols
 Dietary Supplement: Flavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Dietary Supplement: Flavanol free intervention
Calorically, micro- and macronutrient matched control product free of flavanols
Active Comparator: Flavanol rich product B
500 mg flavanols
 Dietary Supplement: Flavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Dietary Supplement: Flavanol free intervention
Calorically, micro- and macronutrient matched control product free of flavanols
Active Comparator: Flavanol rich product C
750 mg flavanols
 Dietary Supplement: Flavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Dietary Supplement: Flavanol free intervention
Calorically, micro- and macronutrient matched control product free of flavanols
Placebo Comparator: Flavanol free product
flavanol free
 Dietary Supplement: Flavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)


Outcome Measures
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Primary Outcome Measures :
  1. Absolute change of Flow-mediated Vasodilation (FMD) [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Pulse wave velocity [ Time Frame: 2 hours ]
    Measured by SphygmoCor

  2. Augmentation index [ Time Frame: 2 hours ]
    Measured by SphygmoCor

  3. Ambulatory blood pressure [ Time Frame: 2 hours ]
    automatical measurements

  4. Plasma flavanol metabolites [ Time Frame: 2 hours ]
    Measured by HPLC

  5. laboratory safety parameters [ Time Frame: 2 hours ]
    blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis)


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy post-menopausal femal subjects (>50 years)
  • healthy male subjects (>50 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
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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): NCT02147223


Locations
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Germany
Division of Cardiology, Pulmonology and Vascular Medicine
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Christian Heiss, MD Division of Cardiology, Pulmonology and Vascular Medicine
Principal Investigator: Ana Rodriguez Mateos, PhD Division of Cardiology, Pulmonology and Vascular Medicine
Study Chair: Malte Kelm, MD Division of Cardiology, Pulmonology and Vascular Medicine
More Information
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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02147223    
Other Study ID Numbers: BRANDED
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
flavanols
sex-related cardiovascular effects
Additional relevant MeSH terms:
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Cardiovascular Diseases