The Water-Blueberry Study

Study Overview
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Brief Summary
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We will study the effect of supplementation of 1 L blueberry juice to participants with at least one elevated cardiovasculat risk factor.

Detailed Description
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Participants with at leat one elevated cardiovacsular risk factor, as defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio >4 or smoking a minimum of 3 cigarettes daily. Subjects were randomized to two groups, where the blueberry group were supplemented with 1 L blueberry juice per day for four weeks. The control group consumed an equal amount of water. Clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation were measured in blood samples before amd after the intervention period.

Official Title
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The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Blueberry juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30-70 years for men and 45-70 years or at least 12 months postmenopausal for women at least one elevated cardiovascular risk factor, defined as systolic blood pressure between 140 and 165 mmHg, diastolic blood pressure between 90 and 105 mmHg, low density lipoprotein (LDL) cholesterol ≥3.4 mmol/L, total/high density lipoprotein (HDL) cholesterol ratio >4 or smoking a minimum of 3 cigarettes daily. Exclusion Criteria: clinically recognized chronic diseases as impaired renal function, diabetes mellitus, cardiovascular disease, liver or gastrointestinal disease or cancer within the last 5 years use of lipid-lowering drugs, diuretics or hormone replacement therapy for women Subjects with a body-mass index ≥31 with a alcohol consumption above 3 units/day for men and 1 unit/day for women blood donation within the last six months

Ages Eligible for Study
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Minimum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Blueberry juice|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoints are cardiovascular risk factors |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular disease, Blueberruy, Antioxidants, Oxidative stress, Inflammation