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| ID | Type | Description | Link |
|---|---|---|---|
| FLA-111-CH | Other Identifier | Flaviola |
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| Name | Class |
|---|---|
| University of Reading | OTHER |
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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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flavanol rich intervention | Active Comparator | flavanol rich drink |
|
| flavanol free intervention | Placebo Comparator | flavanol free drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol rich intervention | Dietary Supplement | Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Flow mediated dilatation (FMD) | change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma flavanol metabolites | Measured by HPLC | analysis of metabolites between first treatment at day 0 and after last treatment at day 14 |
| Ambulatory blood pressure | automatical measurements |
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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 |
| 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 | North Rhine-Westphalia | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26013912 | Derived | Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Flavanol free control | Dietary Supplement | Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks |
|
| blood pressure at day 0 and at day 14 |
| Pulse wave velocity | Measured by SphygmoCor | 14 days |
| Microvascular function | Measured by Laserdoppler perfusion imaging (LDPI) | 14 days |
| Augmentation index | Measured by SphygmoCor | 14 days |
| Heart rate | Measured by ECG | 14 days |
| Erythrocyte deformability | Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA) | 14 days |
| NO bioavailability | Measured by CLD | 14 days |