Age-dependent Effects of Flavanols on Vascular Status

Study Overview
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Brief Summary
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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.

Official Title
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Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Flavanol rich intervention
* Dietary Supplement: Flavanol free control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: flavanol rich intervention<br>flavanol rich drink | Dietary Supplement: Flavanol rich intervention<br>* Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks<br>|
| Placebo Comparator: flavanol free intervention<br>flavanol free drink | Dietary Supplement: Flavanol free control<br>* Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavanols, age related cardiovascular effects