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Completed

NCT Number: NCT02147223

Sex-dependent Effects of Flavanols on Vascular Status

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flavanol rich intervention

Dietary Supplement

Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)

Flavanol free intervention

Dietary Supplement

Calorically, micro- and macronutrient matched control product free of flavanols

Primary outcomes

  1. Absolute change of Flow-mediated Vasodilation (FMD)

    Time frame: 2 hours

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 26, 2014
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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