Cardiovascular Diseases
Conditions
Keywords
flavanols, age related cardiovascular effects
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFlavanol rich intervention
Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks
DIETARY_SUPPLEMENTFlavanol free control
Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks
Sponsors
University of Reading
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male participants between 18-35 years * healthy male participants between 50-80 years
Exclusion criteria
* acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * CRP \> 1 mg/dl * malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14 | Flow mediated dilatation (FMD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory blood pressure | blood pressure at day 0 and at day 14 | automatical measurements |
| Pulse wave velocity | 14 days | Measured by SphygmoCor |
| Microvascular function | 14 days | Measured by Laserdoppler perfusion imaging (LDPI) |
| Plasma flavanol metabolites | analysis of metabolites between first treatment at day 0 and after last treatment at day 14 | Measured by HPLC |
| Heart rate | 14 days | Measured by ECG |
| Erythrocyte deformability | 14 days | Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA) |
| NO bioavailability | 14 days | Measured by CLD |
| Augmentation index | 14 days | Measured by SphygmoCor |
Countries
Germany
Outcome results
None listed