Back to resultsThe Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
Primary Purpose
Pre-hypertension, Hypertension
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Placebo
Mana-juice
Optijuice
Sponsored by
About this trial
This is an interventional prevention trial for Pre-hypertension
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention)
- Participation in a drug trial during the previous 30 days
Sites / Locations
- University of Oslo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control
Mana-juice
Optijuice
Arm Description
12 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.
12 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.
12 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.
Outcomes
Primary Outcome Measures
Systolic and diastolic blood pressure
Change in blood pressure from baseline to 6 weeks and 12 weeks
Platelet aggregation
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Cardiovascular disease risk factors
The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.
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.
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).
Secondary Outcome Measures
Polymorphisms in cardiovascular disease related genes
Single nucleotide polymorphisms will be analyzed and eventually grouped and compared with the mentioned outcome measures to reveal individual mechanisms of the hypothetized effects of the intervention.
Whole genome transcription profiles and methylation patterns
Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.
Full Information
NCT ID
NCT01568983
First Posted
March 7, 2012
Last Updated
June 29, 2012
Sponsor
University of Oslo
Collaborators
Fellesjuice AS, Nofima
1. Study Identification
Unique Protocol Identification Number
NCT01568983
Brief Title
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
Official Title
The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Fellesjuice AS, Nofima
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-hypertension, Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
12 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.
Arm Title
Mana-juice
Arm Type
Active Comparator
Arm Description
12 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.
Arm Title
Optijuice
Arm Type
Active Comparator
Arm Description
12 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Mana-juice
Intervention Description
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
Intervention Type
Dietary Supplement
Intervention Name(s)
Optijuice
Intervention Description
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
Primary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Description
Change in blood pressure from baseline to 6 weeks and 12 weeks
Time Frame
Screening, baseline, 6 and 12 weeks
Title
Platelet aggregation
Description
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Time Frame
Baseline and 12 weeks
Title
Cardiovascular disease risk factors
Description
The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.
Time Frame
Baseline and 12 weeks
Title
Diabetes related parameters in blood and urine
Description
The effect of different doses and types of polyphenoles on diabetes related biomarkers in blood and urine will be analyzed.
Time Frame
Baseline and 12 weeks
Title
Blood cell expression of stress-response and CVD related genes
Description
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).
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Polymorphisms in cardiovascular disease related genes
Description
Single nucleotide polymorphisms will be analyzed and eventually grouped and compared with the mentioned outcome measures to reveal individual mechanisms of the hypothetized effects of the intervention.
Time Frame
Baseline
Title
Whole genome transcription profiles and methylation patterns
Description
Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention)
Participation in a drug trial during the previous 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Blomhoff, PhD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
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