The Water-Blueberry Study

Phase 2CompletedNCT00520871

University of Oslo62 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Disease

Interventions

Blueberry juiceDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary endpoints are cardiovascular risk factors

Time frame: 4 weeks

Secondary Outcomes

Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation

Time frame: 4 weeks

Data from ClinicalTrials.gov

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