Hypertension, Pre-hypertension
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
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
DIETARY_SUPPLEMENTMana-juice
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
DIETARY_SUPPLEMENTOptijuice
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
Sponsors
Fellesjuice AS
Nofima
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation | Baseline and 12 weeks | Change in platelet aggregation from intervention start till end analyzed by PFA100. |
| 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). |
| Systolic and diastolic blood pressure | Screening, baseline, 6 and 12 weeks | Change in blood pressure from baseline to 6 weeks and 12 weeks |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole genome transcription profiles and methylation patterns | Baseline and 12 weeks | Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed. |
| 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. |
Countries
Norway
Outcome results
None listed