Sex-dependent Effects of Flavanols on Vascular Status

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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.

Official Title
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Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Flavanol rich intervention
* Dietary Supplement: Flavanol free intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy post-menopausal femal subjects (>50 years) healthy male subjects (>50 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: 50 Years

Sexes Eligible for Study
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All

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 product A<br>250 mg flavanols | Dietary Supplement: Flavanol rich intervention<br>* Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)<br>Dietary Supplement: Flavanol free intervention<br>* Calorically, micro- and macronutrient matched control product free of flavanols<br>|
| Active Comparator: Flavanol rich product B<br>500 mg flavanols | Dietary Supplement: Flavanol rich intervention<br>* Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)<br>Dietary Supplement: Flavanol free intervention<br>* Calorically, micro- and macronutrient matched control product free of flavanols<br>|
| Active Comparator: Flavanol rich product C<br>750 mg flavanols | Dietary Supplement: Flavanol rich intervention<br>* Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)<br>Dietary Supplement: Flavanol free intervention<br>* Calorically, micro- and macronutrient matched control product free of flavanols<br>|
| Placebo Comparator: Flavanol free product<br>flavanol free | Dietary Supplement: Flavanol rich intervention<br>* Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change of Flow-mediated Vasodilation (FMD) |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity | Measured by SphygmoCor | 2 hours | 
| Augmentation index | Measured by SphygmoCor | 2 hours | 
| Ambulatory blood pressure | automatical measurements | 2 hours | 
| Plasma flavanol metabolites | Measured by HPLC | 2 hours | 
| laboratory safety parameters | blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis) | 2 hours | 

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