Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Study Overview
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Brief Summary
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Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.

Official Title
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Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: flavanol
* Dietary Supplement: methylxanthine
* Dietary Supplement: flavanol + methylxanthine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects >18 years Exclusion Criteria: acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) diabetes mellitus CRP > 1 mg/dl malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavanol rich drink intervention<br>flavanol rich drink | Dietary Supplement: flavanol<br> <br> |
| Active Comparator: methylxanthine rich drink intervention<br>methylxanthine rich drink | Dietary Supplement: methylxanthine<br> <br> |
| Active Comparator: flavanol + methylxanthine rich drink intervention<br>flavanol + methylxanthine rich drink | Dietary Supplement: flavanol + methylxanthine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow mediated dilatation (FMD) | 2 hours | 
| Plasma flavanol metabolites | Measured by HPLC | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity | Measured by SphygmoCor | 2 hours | 
| Ambulatory blood pressure | automatical measurements | 2 hours | 
| Circulation angiogenetic cells |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavanols, cardiovascular effects, nutrition-nutrition interaction