The Water-Blueberry Study

Sponsor

University of Oslo (Other)

Overall Status

Completed

CT.gov ID

NCT00520871

Collaborator

Ullevaal University Hospital (Other)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Blueberry juice	Phase 1/Phase 2

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

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Primary endpoints are cardiovascular risk factors [4 weeks]

Secondary Outcome Measures

Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

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