CHOC: Cardiovascular Health Effects of Flavanol Rich Chocolate

• Sponsor: Wageningen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01308892
• Collaborator: Top Institute Food and Nutrition (Other)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood pressure [0, 4wk]

2. FMD [0, 4wk]

3. PWA [0, 4wk]

Secondary Outcome Measures

1. leukocyte count and activation [0, 4wk]

2. PBMC gene expression [0, 4wk]

3. Markers of inflammation and ED [0, 4wk]

4. Blood pressure [0 and 2h]

   acute study part

5. FMD [0 and 2hrs]

   acute study part

6. PWA [0 and 2 hrs]

   acute study part

7. Leukocyte count and activation [0 and 2 hrs]

   acute study part

8. PBMC gene expression [0 and 2 hrs]

   acute study part

9. markers of inflammation and ED [0 and 2hrs]

   acute study part

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01308892
• Other Study ID Numbers: NL33506.081.10
• First Posted: Mar 4, 2011
• Last Update Posted: Jun 17, 2011
• Last Verified: Jun 1, 2011

Study Results

No Results Posted as of Jun 17, 2011