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Completed

NCT Number: NCT00520871

The Water-Blueberry Study

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

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blueberry juice

Drug

Primary outcomes

  1. Primary endpoints are cardiovascular risk factors

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Ullevaal University Hospital

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Aug 27, 2007
Registry last updated
Aug 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.