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The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects

This study has been completed.
Sponsor:
Collaborators:
Fellesjuice AS
Nofima Mat AS
Information provided by (Responsible Party):
Rune Blomhoff, University of Oslo
ClinicalTrials.gov Identifier:
NCT01568983
First received: March 7, 2012
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pre-hypertension
Hypertension
 Dietary Supplement: Placebo
Dietary Supplement: Mana-juice
Dietary Supplement: Optijuice
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Systolic and diastolic blood pressure [ Time Frame: Screening, baseline, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure from baseline to 6 weeks and 12 weeks

  • Platelet aggregation [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in platelet aggregation from intervention start till end analyzed by PFA100.

  • Cardiovascular disease risk factors [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.

  • Diabetes related parameters in blood and urine [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.


Enrollment: 153
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control

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.

 Dietary Supplement: Placebo
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
Active Comparator: Mana-juice

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.

 Dietary Supplement: Mana-juice
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
Active Comparator: Optijuice

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.

 Dietary Supplement: Optijuice
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568983

Locations
Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Fellesjuice AS
Nofima Mat AS
Investigators
Principal Investigator: Rune Blomhoff, PhD University of Oslo
  More Information

No publications provided

Responsible Party: Rune Blomhoff, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01568983     History of Changes
Other Study ID Numbers: Optijuice
Study First Received: March 7, 2012
Last Updated: June 29, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013