Cardiovascular Health Effects of Flavanol Rich Chocolate

Endothelial Dysfunction Clinical Trial

— CHOC  

Official title:

Cardiovascular Health Effects of Flavanol Rich Chocolate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308892
• Other study ID #: NL33506.081.10
• Status: Completed
• Phase: N/A
• First received: February 15, 2011
• Last updated: June 16, 2011
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Dietary Supplement:
• High flavanol chocolate
chocolate high in flavanols
• Low flavanol chocolate
chocolate low in flavanols
• High fat challenge
Milkshake with 95g fat

Locations

Country	Name	City	State
Netherlands	Wageningen universiteit division of human	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		0, 4wk	No
Primary	FMD		0, 4wk	No
Primary	PWA		0, 4wk	No
Secondary	leukocyte count and activation		0, 4wk	No
Secondary	PBMC gene expression		0, 4wk	No
Secondary	Markers of inflammation and ED		0, 4wk	No
Secondary	Blood pressure	acute study part	0 and 2h	No
Secondary	FMD	acute study part	0 and 2hrs	No
Secondary	PWA	acute study part	0 and 2 hrs	No
Secondary	Leukocyte count and activation	acute study part	0 and 2 hrs	No
Secondary	PBMC gene expression	acute study part	0 and 2 hrs	No
Secondary	markers of inflammation and ED	acute study part	0 and 2hrs	No