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Completed

NCT Number: NCT01568983

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

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.

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Key information

Conditions

Pre-Hypertension Cardiovascular Diseases Hypertension Prehypertension Vascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Oslo

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Dietary Supplement

500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g

Optijuice

Dietary Supplement

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

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: Screening, baseline, 6 and 12 weeks

    Change in blood pressure from baseline to 6 weeks and 12 weeks

  2. Platelet aggregation

    Time frame: Baseline and 12 weeks

    Change in platelet aggregation from intervention start till end analyzed by PFA100.

  3. Cardiovascular disease risk factors

    Time frame: Baseline and 12 weeks

    The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.

  4. Diabetes related parameters in blood and urine

    Time frame: Baseline and 12 weeks

    The effect of different doses and types of polyphenoles on diabetes related biomarkers in blood and urine will be analyzed.

  5. Blood cell expression of stress-response and CVD related genes

    Time frame: 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 outcomes

  1. Polymorphisms in cardiovascular disease related genes

    Time frame: 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.

  2. Whole genome transcription profiles and methylation patterns

    Time frame: Baseline and 12 weeks

    Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Fellesjuice AS
  • Nofima

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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