Cardiovascular Health Effects of Flavanol Rich Chocolate

NCT ID: NCT01308892

Last Updated: 2011-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High flavaonol chocolate

Group Type ACTIVE_COMPARATOR

High flavanol chocolate

Intervention Type DIETARY_SUPPLEMENT

chocolate high in flavanols

High fat challenge

Intervention Type DIETARY_SUPPLEMENT

Milkshake with 95g fat

Low flavanol chocolate

Group Type PLACEBO_COMPARATOR

Low flavanol chocolate

Intervention Type DIETARY_SUPPLEMENT

chocolate low in flavanols

High fat challenge

Intervention Type DIETARY_SUPPLEMENT

Milkshake with 95g fat

Interventions

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High flavanol chocolate

chocolate high in flavanols

Intervention Type DIETARY_SUPPLEMENT

Low flavanol chocolate

chocolate low in flavanols

Intervention Type DIETARY_SUPPLEMENT

High fat challenge

Milkshake with 95g fat

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Wageningen University

Principal Investigators

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Michael Müller, Prof.Dr

Role: STUDY_CHAIR

Chair Department of human nutrition NMG group

Locations

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Wageningen universiteit division of human

Wageningen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL33506.081.10

Identifier Type: -

Identifier Source: org_study_id

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