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OpenTrials
Completed

NCT Number: NCT01639781

Age-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. 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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Division of Cardiology, Pulmonology and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Flavanol rich intervention

Dietary Supplement

Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks

Flavanol free control

Dietary Supplement

Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks

Primary outcomes

  1. 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 outcomes

  1. Plasma flavanol metabolites

    Time frame: analysis of metabolites between first treatment at day 0 and after last treatment at day 14

    Measured by HPLC

  2. Ambulatory blood pressure

    Time frame: blood pressure at day 0 and at day 14

    automatical measurements

  3. Pulse wave velocity

    Time frame: 14 days

    Measured by SphygmoCor

  4. Microvascular function

    Time frame: 14 days

    Measured by Laserdoppler perfusion imaging (LDPI)

  5. Augmentation index

    Time frame: 14 days

    Measured by SphygmoCor

  6. Heart rate

    Time frame: 14 days

    Measured by ECG

  7. Erythrocyte deformability

    Time frame: 14 days

    Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)

  8. NO bioavailability

    Time frame: 14 days

    Measured by CLD

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • University of Reading

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 13, 2012
Registry last updated
Dec 16, 2014

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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