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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pre-hypertension, Hypertension

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Mana-juice
* Dietary Supplement: Optijuice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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<br>* 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<br>|
| Active Comparator: Mana-juice<br>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<br>* 500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g<br>|
| Active Comparator: Optijuice<br>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<br>* 500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g<br>|

What is the study measuring?
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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 |