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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Pre-hypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Mana-juice; Dietary supplement: Optijuice

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 3

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Whole genome transcription profiles and methylation patterns	Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Nofima; Fellesjuice AS

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (ESTIMATE): April 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2012
• Last Update Submitted That Met QC Criteria: June 29, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: Optijuice