HypertensionPhase 2NCT00167869
LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
A Phase 2 study testing dairy peptides in people with Hypertension, run by Wageningen University at 1 site in Netherlands.
Trial summary
Hypertension is an increasingly important medical and public health issue. Literature suggests that there may be a role for dairy foods in the prevention and treatment of hypertension. Recently, it has been suggested that several peptides in milk proteins could have blood pressure lowering properties. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- dairy peptides
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 135 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2004to Jun 2005
- Phase
- Phase 2
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systolic blood pressure >= 140 mmHg
- BMI between 18 and 32 kg/m2
- apparently healthy
Who cannot join
- antihypertensive medication
- medically prescribed or slimming diet
- lactating, pregnant
- irregular pulse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, 6700 EV
About this study
Hypertension is an increasingly important medical and public health issue. Literature suggests that there may be a role for dairy foods in the prevention and treatment of hypertension. Recently, it has been suggested that several peptides in milk proteins could have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.
- Conditions
- Hypertension
- Being tested
- dairy peptides
- Keywords
- hypertension, blood pressure, dairy 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.
dairy peptidesBehavioural
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 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 135 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Investigators
- Frans J Kok, PhD, Principal investigator, Wageningen University - Division of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167869
- Sponsor's protocol ID
- METC-WU 04/04
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
- ClinicalTrials.gov ID
- NCT00167869
- Acronym / sponsor ID
- METC-WU 04/04
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure, dairy peptides, bioactive peptides, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 14 Sep 2005 (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.
Hypertension is an increasingly important medical and public health issue. Literature suggests that there may be a role for dairy foods in the prevention and treatment of hypertension. Recently, it has been suggested that several peptides in milk proteins could have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel trial to assess the blood pressure effect of an increased intake of dairy peptides in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- systolic blood pressure >= 140 mmHg
- BMI between 18 and 32 kg/m2
- apparently healthy
Key exclusion criteria (4 listed)
- antihypertensive medication
- medically prescribed or slimming diet
- lactating, pregnant
- irregular pulse
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 |
|---|---|---|
| dairy peptides | Behavioural | – |
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 29 May 2008.
- Division of Human Nutrition, Wageningen UniversityLink provided by the sponsor.
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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.
Frans J Kok, PhD principal investigator
Wageningen University - Division of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dairy peptides in people with Hypertension, run by Wageningen University at 1 site in Netherlands.
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 4 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 29 May 2008. 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 Netherlands. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 May 2008.