The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 62
- Primary Endpoint
- Primary endpoints are cardiovascular risk factors
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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(4 weeks)