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Clinical Trials/NCT01308892
NCT01308892
Completed
Not Applicable

Cardiovascular Health Effects of Flavanol Rich Chocolate

Wageningen University1 site in 1 country44 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
Wageningen University
Enrollment
44
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Blood pressure

Time Frame: 0, 4wk

FMD

Time Frame: 0, 4wk

PWA

Time Frame: 0, 4wk

Secondary Outcomes

  • leukocyte count and activation(0, 4wk)
  • PBMC gene expression(0 and 2 hrs)
  • Markers of inflammation and ED(0, 4wk)
  • Blood pressure(0 and 2h)
  • FMD(0 and 2hrs)
  • PWA(0 and 2 hrs)
  • Leukocyte count and activation(0 and 2 hrs)
  • markers of inflammation and ED(0 and 2hrs)

Study Sites (1)

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