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Atherosclerosis progressively occurs with increasing age in the general population. So far most dietary intervention studies with flavanols were performed over short time frames and in small groups of young healthy and older patients with manifest cardiovascular disease, respectively. Vascular health is defined as absence of vascular disease and the presence of optimal parameters that determine the development and progression of arteriosclerosis (endothelial function, blood pressure, plasma lipids, and glucose). It is not clear whether flavanols can improve parameters of vascular health, most importantly endothelial function, when given repetitively to healthy middle aged and which factors affect the efficacy of flavanol interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flavanol rich intervention | Active Comparator | Ingestion of 410mg flavanols twice a day for 30 days |
|
| flavanol free intervention | Placebo Comparator | Ingestion of a macro and micro nutrients matched flavanol free drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol (410 mg) | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Time points: day 0 [baseline], and day 30 each 0 and 2h. | |
| Glucose | Time points: day 0 [baseline], and day 30 each 0 and 2h. | |
| Plasma lipids |
| Measure | Description | Time Frame |
|---|---|---|
| Flavanol metabolites | day 0 [baseline], and day 30 each 0 and 2h | |
| Microparticles | Time points: day 0 [baseline], and day 30 each 0 and 2h. | |
| Dietary pattern |
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 |
|---|---|---|---|
| 26348767 | Derived | Sansone R, Rodriguez-Mateos A, Heuel J, Falk D, Schuler D, Wagstaff R, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M, Heiss C; Flaviola Consortium, European Union 7th Framework Program. Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study. Br J Nutr. 2015 Oct 28;114(8):1246-55. doi: 10.1017/S0007114515002822. Epub 2015 Sep 9. |
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| Control (no flavanols) | Dietary Supplement |
|
|
| Time points: day 0 [baseline], and day 30 each 0 and 2h. |
| Time points: day 0 [baseline] and day 30 |
| Vascular stiffness | Time points: day 0 [baseline], and day 30 each 0 and 2h. |
| Microvascular function | Time points: day 0 [baseline], and day 30 each 0 and 2h. |