Pre-hypertensionPhase 3NCT01568983
The Effects of Polyphenol-rich Berry Juice on Blood Pressure in Hypertensive Subjects
A Phase 3 study testing Mana-juice and Optijuice in people with Pre-hypertension and Hypertension, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension, Hypertension
- What is being tested?
- Mana-juice and Optijuice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2011to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-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.
- Conditions
- Pre-hypertension, Hypertension
- Being tested
- Placebo, Mana-juice, Optijuice
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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-juiceDietary supplement
500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
OptijuiceDietary supplement
500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Mana-juice | Active comparator | 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. Receives: Dietary Supplement: Mana-juice |
| Optijuice | Active comparator | 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. Receives: Dietary Supplement: Optijuice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressure
Change in blood pressure from baseline to 6 weeks and 12 weeks
Measured: Screening, baseline, 6 and 12 weeks
Platelet aggregation
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 12 weeks
Secondary outcomes (2)
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.
Measured: Baseline
Whole genome transcription profiles and methylation patterns
Effects of polyphenoles on transcription profiles and methylation pattern will be analyzed.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Fellesjuice AS, Nofima
- Responsible party
- Principal investigator, Rune Blomhoff, University of Oslo
- Investigators
- Rune Blomhoff, PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568983
- Sponsor's protocol ID
- Optijuice
- Status last verified
- Jun 2012
- First submitted
- 7 Mar 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects
- ClinicalTrials.gov ID
- NCT01568983
- Acronym / sponsor ID
- Optijuice
- Conditions
- Pre-hypertension, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Fellesjuice AS, Nofima
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo12 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. |
| Mana-juice | Active comparator | Dietary Supplement: Mana-juice12 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. |
| Optijuice | Active comparator | Dietary Supplement: Optijuice12 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo500 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 supplement | Control |
| Mana-juice500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g | Dietary supplement | Mana-juice |
| Optijuice500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g | Dietary supplement | Optijuice |
Primary outcome
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
Platelet aggregation
Time frame: Baseline and 12 weeks
Change in platelet aggregation from intervention start till end analyzed by PFA100.
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.
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.
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).
2 secondary outcomes
Polymorphisms in cardiovascular disease related genes
Time frame: Baseline
Whole genome transcription profiles and methylation patterns
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Blomhoff, PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mana-juice and Optijuice in people with Pre-hypertension and Hypertension, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressure (time frame: Screening, baseline, 6 and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.