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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flavanol rich product A | Active Comparator | 250 mg flavanols |
|
| Flavanol rich product B | Active Comparator | 500 mg flavanols |
|
| Flavanol rich product C | Active Comparator | 750 mg flavanols |
|
| Flavanol free product | Placebo Comparator | flavanol free |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol rich intervention | Dietary Supplement | Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change of Flow-mediated Vasodilation (FMD) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse wave velocity | Measured by SphygmoCor | 2 hours |
| Augmentation index | Measured by SphygmoCor | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Heiss, MD | Division of Cardiology, Pulmonology and Vascular Medicine | Principal Investigator |
| Ana Rodriguez Mateos, PhD | Division of Cardiology, Pulmonology and Vascular Medicine | Principal Investigator |
| Malte Kelm, MD | Division of Cardiology, Pulmonology and Vascular Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonology and Vascular Medicine | Düsseldorf | 40225 | Germany |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Flavanol free intervention | Dietary Supplement | Calorically, micro- and macronutrient matched control product free of flavanols |
|
| 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 |