Cardiovascular Diseases
Conditions
Keywords
flavanols, sex-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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.
Interventions
DIETARY_SUPPLEMENTFlavanol rich intervention
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)
DIETARY_SUPPLEMENTFlavanol free intervention
Calorically, micro- and macronutrient matched control product free of flavanols
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change of Flow-mediated Vasodilation (FMD) | 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory blood pressure | 2 hours | automatical measurements |
| Plasma flavanol metabolites | 2 hours | Measured by HPLC |
| laboratory safety parameters | 2 hours | blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis) |
| Pulse wave velocity | 2 hours | Measured by SphygmoCor |
| Augmentation index | 2 hours | Measured by SphygmoCor |
Countries
Germany
Outcome results
None listed