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Clinical Trials/NCT00520871
NCT00520871
Completed
Phase 1

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

University of Oslo0 sites62 target enrollmentMarch 2003

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
University of Oslo
Enrollment
62
Primary Endpoint
Primary endpoints are cardiovascular risk factors
Status
Completed
Last Updated
18 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
April 2004
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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)

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