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

Phase 3

Completed

• Conditions: Pre-hypertension; Hypertension
• Interventions: Dietary Supplement: Mana-juice; Dietary Supplement: Optijuice; Dietary Supplement: Placebo

• Registration Number: NCT01568983
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mana-juice	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.
Optijuice	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.
Control	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Oslo; 🇳🇴 Oslo, Norway