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Completed

NCT Number: NCT02149238

Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

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.

However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

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 male subjects
  • >18 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

Dietary Supplement

methylxanthine

Dietary Supplement

flavanol + methylxanthine

Dietary Supplement

Primary outcomes

  1. Endothelial function

    Time frame: 2 hours

    Flow mediated dilatation (FMD)

  2. Plasma flavanol metabolites

    Time frame: 2 hours

    Measured by HPLC

Secondary outcomes

  1. Pulse wave velocity

    Time frame: 2 hours

    Measured by SphygmoCor

  2. Ambulatory blood pressure

    Time frame: 2 hours

    automatical measurements

  3. Circulation angiogenetic cells

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Acronym: New Drink

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 29, 2014
Registry last updated
Dec 23, 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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