The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
1 other identifier
interventional
153
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of berry juices containing different levels of polyphenols on blood pressure and other cardiovascular risk factors. The study is a 12 week double blinded randomized controlled intervention trial. The subjects will be divided in three groups where one receives a placebo juice while the two other will consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be monitored and blood samples will be taken.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 7, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 3, 2012
June 1, 2012
6 months
March 7, 2012
June 29, 2012
Conditions
Outcome Measures
Primary Outcomes (5)
Systolic and diastolic blood pressure
Change in blood pressure from baseline to 6 weeks and 12 weeks
Screening, baseline, 6 and 12 weeks
Platelet aggregation
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Baseline and 12 weeks
Cardiovascular disease risk factors
The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.
Baseline and 12 weeks
Diabetes related parameters in blood and urine
The effect of different doses and types of polyphenoles on diabetes related biomarkers in blood and urine will be analyzed.
Baseline and 12 weeks
Blood cell expression of stress-response and CVD related genes
Effect of polyphenole-rich diet on blood cell expression of stress-response and cardiovascular disease related genes by low density array and/or whole genome expression (microarray).
Baseline and 12 weeks
Secondary Outcomes (2)
Polymorphisms in cardiovascular disease related genes
Baseline
Whole genome transcription profiles and methylation patterns
Baseline and 12 weeks
Study Arms (3)
Control
PLACEBO COMPARATOR12 weeks intake of 0.5 liter/day placebo juice containing sugar, aromas and salt corresponding to the berry juices in the other groups. Blood pressure will be taken at time point 0,6 and 12 weeks. Blood and urine samples will be collected and weight and bioelectric impedance will be monitored at time point 0 and 12 weeks.
Mana-juice
ACTIVE COMPARATOR12 weeks intake of 0.5 liter/day of a commercially available berry juice (Mana blue) rich in polyphenols (grape, cherries, bilberries and aronia). Blood pressure will be taken at time point 0,6 and 12 weeks. Blood and urine samples will be collected and weight and bioelectric impedance will be monitored at time point 0 and 12 weeks.
Optijuice
ACTIVE COMPARATOR12 weeks intake of 0.5 liter/day of berry juice rich in polyphenols (grape, cherries, blueberry and aronia) and added extract from press cake of black currant. Blood pressure will be taken at time point 0,6 and 12 weeks. Blood and urine samples will be collected and weight and bioelectric impedance will be monitored at time point 0 and 12 weeks.
Interventions
500 ml/day Per 100g 6.25 g sucrose 6.25 g maltodextrin 1.3 g citric acid E330 (pH 3.0) 2.5 g Carmine solution E120 (4% carmine colouring agent) 0.025 g blueberry aroma Potassium sorbate E202 water
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
Eligibility Criteria
You may qualify if:
- Pre-hypertension or hypertension systolic blood pressure in the 130-179 mmHg range and/or diastolic blood pressure in the 85-109 mmHg range)
- BMI 20-35 kg/m2
- Stable weight (change \<4 kg previous 12 weeks)
You may not qualify if:
- Regular use of blood pressure lowering agens
- Diabetes type I or II
- Smokers
- Allergy to grape, cherries, blueberries/bilberries, black currant, aronia
- Supplements for weight loss
- Participation in a drug trial during the previous 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- Fellesjuice AScollaborator
- Nofimacollaborator
Study Sites (1)
University of Oslo
Oslo, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rune Blomhoff, PhD
University of Oslo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 7, 2012
First Posted
April 2, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 3, 2012
Record last verified: 2012-06