- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399737
Effects of Peptides Derived From Fermented Milk on Blood Pressure Regulation System in Healthy Volunteers.
November 14, 2006 updated by: Assistance Publique - Hôpitaux de Paris
Several milk proteins are precursors of peptides, released during fermentation, which possess various biochemical and physiological properties.
Among them, some peptides have been reported to inhibit angiotensin-converting enzyme (ACE) in vitro (an enzyme implicated in blood pressure regulation) and to lower blood pressure (BP). in hypertensive rats and in a small sample of patients with hypertension.
One possible mechanism for the BP lowering effect is inhibition of ACE.
Prior investigating BP lowering effect of these peptides in a large cohort of hypertensive patients, it is necessary to assess in depth their potency to inhibit ACE in vivo in humans and to compare it to that induced by a well-known ACE inhibitor.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
12
Phase
- Phase 1
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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-
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Paris, France, 75015
- Clinical Investigation Center 920, Hôpital Européen Georges Pompidou
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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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male volunteers
- aged between 18 and 35 years
- informed written consent
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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ACE activity
|
Secondary Outcome Measures
Outcome Measure |
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kinetics/dynamics
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michel Azizi, APHP
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.
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
October 1, 2005
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
November 14, 2006
First Submitted That Met QC Criteria
November 14, 2006
First Posted (Estimate)
November 15, 2006
Study Record Updates
Last Update Posted (Estimate)
November 15, 2006
Last Update Submitted That Met QC Criteria
November 14, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU167
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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