Effects of Cranberry Consumption in Vascular Function in Healthy Individuals

Study Overview
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Brief Summary
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Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk has shown promising results. However, to date, very few human studies have specifically investigated the effects of cranberry (poly)phenols on cardiovascular function in healthy subjects. To our knowledge, no study has investigated the time and intake-dependent effect of cranberry consumption on vascular function in healthy subjects. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of cranberries, using optimal amounts at optimal time points. Therefore, this study aims to investigate the potential role of cranberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma and urine.

Official Title
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Intake and Time-dependent Effects of Cranberry (Poly)Phenol Consumption in Vascular Function in Healthy Individuals

Conditions
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Healthy Men

Intervention / Treatment
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* Dietary Supplement: Cranberry 320
* Dietary Supplement: Cranberry 640
* Dietary Supplement: Cranberry 960
* Dietary Supplement: Cranberry 1280
* Dietary Supplement: Cranberry 1600
* Dietary Supplement: Cranberry deprived supplement


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 Exclusion Criteria: cardiovascular disease acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) diabetes mellitus C-reactive protein > 05 mg/dL malignant disease cranberry allergy/intolerance hypotension (≤100 / 60 mm Hg)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Cranberry 320<br>Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry 320<br>* Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)<br>|
| Active Comparator: Cranberry 640<br>Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry 640<br>* Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)<br>|
| Active Comparator: Cranberry 960<br>Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry 960<br>* Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)<br>|
| Active Comparator: Cranberry 1280<br>Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry 1280<br>* Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)<br>|
| Active Comparator: Cranberry 1600<br>Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry 1600<br>* Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)<br>|
| Placebo Comparator: Cranberry deprived supplement<br>Placebo comparator: Cranberry deprived supplement Acute intake of 500 mL (1x daily) | Dietary Supplement: Cranberry deprived supplement<br>* Cranberry deprived supplement Acute intake of 500 mL (1x daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | measured by Flow mediated dilation at 1, 2, 4, 6 and 8 hours after intake | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse wave velocity | measured by SphygmoCor at 0, 1, 2, 4, 6 and 8 hours after intake | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | 
| Central blood pressure | measured by SphygmoCor at 0, 1.5, 4, 6 and 8 hours after intake | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | 
| Peripheral blood pressure | measured by automatic sphygmomanometer at 0, 1, 2, 4, 6 and 8 hours after intake | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | 
| Heart Rate | measured by SphygmoCor 0, 1, 2, 4, 6 and 8 hours after intake | Baseline, on week 1, 2, 3, 4 and 5 postconsumption | 

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