Cranberry (Poly)Phenol Consumption on Vascular Function

Study Overview
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Brief Summary
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Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.

Official Title
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Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals

Conditions
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Healthy Young

Intervention / Treatment
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* Dietary Supplement: cranberry (poly)phenol containing supplement
* Dietary Supplement: Placebo comparator: cranberry (poly)phenol deprived supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects (no clinical signs or symptoms of CVD) Young >18 years, <35 years Exclusion Criteria: CVD 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: 35 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: freeze dried powder whole cranberry dissolved in water<br>Dietary Supplement: freeze dried cranberry powder | Dietary Supplement: cranberry (poly)phenol containing supplement<br>* Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.<br>|
| Placebo Comparator: freeze dried cranberry deprived powder dissolved in water<br>Placebo comparator: freeze dried cranberry deprived powder | Dietary Supplement: Placebo comparator: cranberry (poly)phenol deprived supplement<br>* Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form Baseline Endothelial function at 1 month | Measured by Flow mediated dilation (FMD) | 2 hours and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity | Measured by SphygmoCor 0 and 2 hours postconsumption | Baseline and 1 month | 
| Blood pressure | automatical measurements 0 and 2 hours postconsumption | Baseline and 1month | 
| high density lipoproteins (HDL) | measured on baseline and after 1 month | Baseline and 1 month | 
| low density lipoproteins (LDL) | measured on baseline and after 1 month | Baseline and 1 month | 
| triglyceride | measured on baseline and after 1 month | Baseline and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function, endothelial function, polyphenols