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

Hypertension Clinical Trial

Official title:

The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568983
• Other study ID #: Optijuice
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2012
• Last updated: June 29, 2012
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Pre-hypertension
• Prehypertension

Intervention

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
• Mana-juice
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
• Optijuice
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Fellesjuice AS, Nofima Mat AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic blood pressure	Change in blood pressure from baseline to 6 weeks and 12 weeks	Screening, baseline, 6 and 12 weeks	No
Primary	Platelet aggregation	Change in platelet aggregation from intervention start till end analyzed by PFA100.	Baseline and 12 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Whole genome transcription profiles and methylation patterns	Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.	Baseline and 12 weeks	No