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

U

University of Oslo

Status and phase

Completed
Phase 3

Conditions

Hypertension
Pre-hypertension

Treatments

Dietary Supplement: Optijuice
Dietary Supplement: Placebo
Dietary Supplement: Mana-juice

Study type

Interventional

Funder types

Other

Identifiers

NCT01568983
Optijuice

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

153 participants in 3 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
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.
Treatment:
Dietary Supplement: Placebo
Mana-juice
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Mana-juice
Optijuice
Active Comparator group
Description:
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.
Treatment:
Dietary Supplement: Optijuice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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