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Cardiovascular Health Effects of Flavanol Rich Chocolate (CHOC)

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ClinicalTrials.gov Identifier: NCT01308892
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : June 17, 2011
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Wageningen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Dietary Supplement: High flavanol chocolate Dietary Supplement: Low flavanol chocolate Dietary Supplement: High fat challenge Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Cardiovascular Health Effects of Flavanol Rich Chocolate
Study Start Date : January 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Active Comparator: High flavaonol chocolate Dietary Supplement: High flavanol chocolate
chocolate high in flavanols
Dietary Supplement: High fat challenge
Milkshake with 95g fat
Placebo Comparator: Low flavanol chocolate Dietary Supplement: Low flavanol chocolate
chocolate low in flavanols
Dietary Supplement: High fat challenge
Milkshake with 95g fat



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 0, 4wk ]
  2. FMD [ Time Frame: 0, 4wk ]
  3. PWA [ Time Frame: 0, 4wk ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT01308892


Locations
Netherlands
Wageningen universiteit division of human
Wageningen, Gelderland, Netherlands, 6703HD
Sponsors and Collaborators
Wageningen University
Top Institute Food and Nutrition
Investigators
Study Chair: Michael Müller, Prof.Dr Chair Department of human nutrition NMG group

Responsible Party: Wageningen universiteit department of human nutrition, Wageningen University
ClinicalTrials.gov Identifier: NCT01308892     History of Changes
Other Study ID Numbers: NL33506.081.10
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011