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

March 7, 2012
June 29, 2012
December 2011
June 2012   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01568983 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pre-hypertension
  • Hypertension
  • 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
  • Dietary Supplement: Mana-juice
    500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
  • Dietary Supplement: Optijuice
    500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
  • 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.

    Intervention: Dietary Supplement: Placebo
  • 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.

    Intervention: Dietary Supplement: Mana-juice
  • 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.

    Intervention: Dietary Supplement: Optijuice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01568983
Optijuice
No
Rune Blomhoff, University of Oslo
University of Oslo
  • Fellesjuice AS
  • Nofima Mat AS
Principal Investigator: Rune Blomhoff, PhD University of Oslo
University of Oslo
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP