Stage 1 HypertensionPhase 3NCT01031485
Bioactive Milk Peptides and Blood Pressure
A Phase 3 study testing Milk peptides and plant sterols in people with Stage 1 Hypertension, run by Valio Ltd at 1 site in Finland.
Trial summary
The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Stage 1 Hypertension
- What is being tested?
- Milk peptides and plant sterols
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Jan 2010to Aug 2010
- 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 30 to 60 years
- All sexes
- Adult
Who may be able to join
- age 30-60 years
- systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement
- apparently healthy
Who cannot join
- antihypertensive and lipid-lowering drugs
- unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension
- BMI > 32 kg/m2
- milk allergy
- smoking
- alcohol abuse
- pregnancy, lactation
- simultaneous participation in other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.
- Conditions
- Stage 1 Hypertension
- Being tested
- Milk peptides and plant sterols, Placebo
- Keywords
- hypertension, blood pressure, milk peptides, bioactive peptides, randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk peptides and plant sterolsDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Spread with milk peptides and plant sterols | Active comparator | Not described Receives: Dietary Supplement: Milk peptides and plant sterols |
| Standard spread | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 1 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Valio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031485
- Sponsor's protocol ID
- Valio-70
- Status last verified
- Dec 2009
- First submitted
- 11 Dec 2009
- Last updated
- 23 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Milk Peptides and Blood Pressure
- ClinicalTrials.gov ID
- NCT01031485
- Acronym / sponsor ID
- Valio-70
- Conditions
- Stage 1 Hypertension
- Keywords
- hypertension, blood pressure, milk peptides, bioactive peptides, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Valio LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Dec 2009 (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 bioactive milk peptides on blood pressure in mildly hypertensive subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spread with milk peptides and plant sterols | Active comparator | Dietary Supplement: Milk peptides and plant sterols |
| Standard spread | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 30-60 years
- systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement
- apparently healthy
Key exclusion criteria (8 listed)
- antihypertensive and lipid-lowering drugs
- unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension
- BMI > 32 kg/m2
- milk allergy
- smoking
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 |
|---|---|---|
| Milk peptides and plant sterols | Dietary supplement | Spread with milk peptides and plant sterols |
| Placebo | Other | Standard spread |
Primary outcome
Blood pressure
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 23 Dec 2014.
Related trials for Stage 1 Hypertension
RecruitingPhase 2
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Active, not recruitingPhase 1
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Hypertension, Hypertension,Essential
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
RecruitingPhase 1/2
A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage
Glaucoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Milk peptides and plant sterols in people with Stage 1 Hypertension, run by Valio Ltd at 1 site in Finland.
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 8 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 23 Dec 2014. 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 Finland. 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?
Blood pressure. 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 23 Dec 2014.