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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Notify MeKey information
Conditions
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
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
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.
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