Cardiovascular Health Effects of Flavanol Rich Chocolate (CHOC)

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: High flavanol chocolate; Dietary supplement: High fat challenge; Dietary supplement: Low flavanol chocolate

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6703HD
      • Wageningen universiteit division of human

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: High fat challenge; Milkshake with 95g fat; Dietary supplement: Low flavanol chocolate; chocolate low in flavanols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	0, 4wk
FMD	0, 4wk
PWA	0, 4wk

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
leukocyte count and activation		0, 4wk
PBMC gene expression		0, 4wk
Markers of inflammation and ED		0, 4wk
Blood pressure	acute study part	0 and 2h
FMD	acute study part	0 and 2hrs
PWA	acute study part	0 and 2 hrs
Leukocyte count and activation	acute study part	0 and 2 hrs
PBMC gene expression	acute study part	0 and 2 hrs
markers of inflammation and ED	acute study part	0 and 2hrs

Collaborators and Investigators

• Sponsor: Wageningen University
• Collaborators: Top Institute Food and Nutrition
• Investigators: Study Chair: Michael Müller, Prof.Dr, Chair Department of human nutrition NMG group

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 17, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: NL33506.081.10