The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

Detailed Description
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The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.

Official Title
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The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk

Conditions
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Blood Pressure, Platelet Function, Inflammation

Intervention / Treatment
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* Other: berry products
* Other: control products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg) Exclusion Criteria: smoking regular use of medications (except hormone replacement therapy) or dietary supplements intestinal disorders obesity (BMI> 35 kg/m2) vegetarianism pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: berry products<br>Berry products | Other: berry products<br>* effects of berry consumption on cardiovascular indicators two portions daily<br>|
| Placebo Comparator: control products<br>Control products | Other: control products<br>* two portions daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 0, 8 and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFA-100 measurement |  | 0, 8 and 16 weeks | 
| biomarkers of cardiovascular disease risk |  | 0, 8 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human, intervention, blood pressure, cardiovascular risk factors, polyphenols, bioavailability