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Cardiovascular Health Effects of Flavanol Rich Chocolate (CHOC)

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT01308892
First received: February 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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 Intervention
Endothelial Dysfunction
Dietary Supplement: High flavanol chocolate
Dietary Supplement: Low flavanol chocolate
Dietary Supplement: High fat challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Cardiovascular Health Effects of Flavanol Rich Chocolate

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • FMD [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • PWA [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • leukocyte count and activation [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • PBMC gene expression [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Markers of inflammation and ED [ Time Frame: 0, 4wk ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 0 and 2h ] [ Designated as safety issue: No ]
    acute study part

  • FMD [ Time Frame: 0 and 2hrs ] [ Designated as safety issue: No ]
    acute study part

  • PWA [ Time Frame: 0 and 2 hrs ] [ Designated as safety issue: No ]
    acute study part

  • Leukocyte count and activation [ Time Frame: 0 and 2 hrs ] [ Designated as safety issue: No ]
    acute study part

  • PBMC gene expression [ Time Frame: 0 and 2 hrs ] [ Designated as safety issue: No ]
    acute study part

  • markers of inflammation and ED [ Time Frame: 0 and 2hrs ] [ Designated as safety issue: No ]
    acute study part


Estimated Enrollment: 44
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wageningen universiteit department of human nutrition, Wageningen University
ClinicalTrials.gov Identifier: NCT01308892     History of Changes
Other Study ID Numbers: NL33506.081.10
Study First Received: February 15, 2011
Last Updated: June 16, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on November 20, 2014