Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism

Study Overview
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Brief Summary
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Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies. Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Wild blueberries have gained attention due to their high content of phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular function and health 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 wild blueberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk.

Official Title
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Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Blueberry Group
* Dietary Supplement: Placebo Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects without clinical signs or symptoms of cardiovascular disease 18-70 years Exclusion Criteria: cardiovascular disease acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) diabetes mellitus C- reactive protein > 1mg/dl malignant disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blueberry Group<br>Dietary Supplement: 22 gram freeze-dried blueberry powder per day | Dietary Supplement: Blueberry Group<br>* 22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water<br>|
| Placebo Comparator: Placebo Group<br>blueberry polyphenol deprived powder 22 gram per day | Dietary Supplement: Placebo Group<br>* Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption | baseline 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 1 month | 
| Blood lipids | biochemical analysis, 0 and 2 hours postconsumption | baseline and 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blueberry polyphenols, Polyphenol metabolites, endothelial function, Molecular mechanisms of action, Vascular function, Healthy men