The Water-Blueberry Study
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Purpose
We will study the effect of supplementation of 1 L blueberry juice to participants with at least one elevated cardiovasculat risk factor.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease |
Drug: Blueberry juice |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | The Effect of Blueberry Juice on Cardiovascular Risk Factors, and Markers of Antioxidant Status, Oxidative Stress Status and Inflammation. |
- Primary endpoints are cardiovascular risk factors [ Time Frame: 4 weeks ]
- Secondary endpoints are additional clinical markers, as well as biomarkers of antioxidant status, oxidative stress status and inflammation [ Time Frame: 4 weeks ]
| Enrollment: | 62 |
| Study Start Date: | March 2003 |
| Study Completion Date: | April 2004 |
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.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Principal Investigator: | Rune Blomhoff, PhD | University of Oslo |
| Principal Investigator: | Serena Tonstad, MD | Ullevaal University Hospital |
| Principal Investigator: | Anette Karlsen, MSc | University of Oslo |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00520871 History of Changes |
| Other Study ID Numbers: | Water-Blueberry Study, REK SØR ref nr 39-03-01166 |
| Study First Received: | August 24, 2007 |
| Last Updated: | August 24, 2007 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by University of Oslo:
|
Cardiovascular disease Blueberruy Antioxidants Oxidative stress Inflammation |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Inflammation Pathologic Processes Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013