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

Sponsor

University of Oslo (Other)

Overall Status

Completed

CT.gov ID

NCT01568983

Collaborator

Fellesjuice AS (Other), Nofima (Other)

153

Enrollment

Location

Arms

Duration (Months)

25.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-hypertension Hypertension	Dietary Supplement: Placebo Dietary Supplement: Mana-juice Dietary Supplement: Optijuice	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

153 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Systolic and diastolic blood pressure [Screening, baseline, 6 and 12 weeks]
Change in blood pressure from baseline to 6 weeks and 12 weeks
Platelet aggregation [Baseline and 12 weeks]
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Cardiovascular disease risk factors [Baseline and 12 weeks]
The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.
Diabetes related parameters in blood and urine [Baseline and 12 weeks]
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 [Baseline and 12 weeks]
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 [Baseline]
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 [Baseline and 12 weeks]
Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Oslo	Oslo		Norway

Sponsors and Collaborators

University of Oslo
Fellesjuice AS
Nofima

Investigators

Principal Investigator: Rune Blomhoff, PhD, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rune Blomhoff, Professor, University of Oslo

ClinicalTrials.gov Identifier:

NCT01568983

Other Study ID Numbers:

Optijuice

First Posted:

Apr 2, 2012

Last Update Posted:

Jul 3, 2012

Last Verified:

Jun 1, 2012

Additional relevant MeSH terms:

Hypertension

Prehypertension

Study Results

No Results Posted as of Jul 3, 2012