The Water-Blueberry Study

Phase 1

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT00520871
• Lead Sponsor: University of Oslo

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2003-03
• Study Completion: 2004-04
• Status Verified: 2007-08
• Study First Submitted: 2007-08-24
• Study First Submitted QC: 2007-08-24
• Last Update Submitted: 2007-08-24
• Study First Posted: 2007-08-27
• Last Update Posted: 2007-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary endpoints are cardiovascular risk factors	4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation	4 weeks