- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167869
LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
May 23, 2008 updated by: Wageningen University
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 Overview
Study Type
Interventional
Enrollment
135
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wageningen, Netherlands, 6700 EV
- Wageningen University, Division of Human Nutrition
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- systolic blood pressure >= 140 mmHg
- BMI between 18 and 32 kg/m2
- apparently healthy
Exclusion Criteria:
- antihypertensive medication
- medically prescribed or slimming diet
- lactating, pregnant
- irregular pulse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Blood pressure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Frans J Kok, PhD, Wageningen University - Division of Human Nutrition
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (ACTUAL)
June 1, 2005
Study Completion (ACTUAL)
June 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 14, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 29, 2008
Last Update Submitted That Met QC Criteria
May 23, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC-WU 04/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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