Cardiovascular Health Effects of Flavanol Rich Chocolate

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Dietary Supplement: High flavanol chocolate; Dietary Supplement: Low flavanol chocolate; Dietary Supplement: High fat challenge

• Registration Number: NCT01308892
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High flavaonol chocolate	High fat challenge	-
High flavaonol chocolate	High flavanol chocolate	-
Low flavanol chocolate	Low flavanol chocolate	-
Low flavanol chocolate	High fat challenge	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	0, 4wk
FMD	0, 4wk
PWA	0, 4wk

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wageningen universiteit division of human; 🇳🇱 Wageningen, Gelderland, Netherlands