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Completed

NCT Number: NCT01308892

Cardiovascular Health Effects of Flavanol Rich Chocolate

In the CHOC study the investigators will examine the effect of chocolate flavanols on vascular function, inflammation, oxidative stress and markers of endothelial function. The effects of both acute consumption and prolonged consumption will be studied. The secondary objectives are to investigate if daily intake of chocolate flavanols for 4 weeks will improve the response to a high fat/high energy challenge.

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Key information

Conditions

Endothelial Dysfunction

Age range

45 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen universiteit division of human

Wageningen, Gelderland, 6703HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male
  • 45-70 years old
  • BMI between 25 and 32 kg/m2

Exclusion criteria

  • Urine glucose concentrations outside normal ranges (> 0,25 g/l)
  • Fasting blood glucose < 7.0 mmol/L)
  • Systolic Bp > 160 mmHg or diastolic Bp > 100 mmHg
  • Blood Hb values below 8.4 mmol/L
  • Allergic to cow milk, dairy products or chocolate
  • Vegetarian
  • Tobacco smoker
  • Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)

Treatment and study plan

High flavanol chocolate

Dietary Supplement

chocolate high in flavanols

Low flavanol chocolate

Dietary Supplement

chocolate low in flavanols

High fat challenge

Dietary Supplement

Milkshake with 95g fat

Primary outcomes

  1. Blood pressure

    Time frame: 0, 4wk

  2. FMD

    Time frame: 0, 4wk

  3. PWA

    Time frame: 0, 4wk

Secondary outcomes

  1. leukocyte count and activation

    Time frame: 0, 4wk

  2. PBMC gene expression

    Time frame: 0, 4wk

  3. Markers of inflammation and ED

    Time frame: 0, 4wk

  4. Blood pressure

    Time frame: 0 and 2h

    acute study part

  5. FMD

    Time frame: 0 and 2hrs

    acute study part

  6. PWA

    Time frame: 0 and 2 hrs

    acute study part

  7. Leukocyte count and activation

    Time frame: 0 and 2 hrs

    acute study part

  8. PBMC gene expression

    Time frame: 0 and 2 hrs

    acute study part

  9. markers of inflammation and ED

    Time frame: 0 and 2hrs

    acute study part

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Acronym: CHOC

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 4, 2011
Registry last updated
Jun 17, 2011

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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