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Effects of Peptides Derived From Fermented Milk on Blood Pressure Regulation System in Healthy Volunteers.

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399737
First Posted: November 15, 2006
Last Update Posted: November 15, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danone Institute International
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention Phase
Healthy Drug: repeated intake of fermented milk followed by a single oral dose of an ACE inhibitor Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • ACE activity

Secondary Outcome Measures:
  • kinetics/dynamics

Estimated Enrollment: 12
Study Start Date: October 2005
Estimated Study Completion Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers
  • aged between 18 and 35 years
  • informed written consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399737


Locations
France
Clinical Investigation Center 920, Hôpital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Danone Institute International
Investigators
Principal Investigator: Michel Azizi APHP
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00399737     History of Changes
Other Study ID Numbers: NU167
First Submitted: November 14, 2006
First Posted: November 15, 2006
Last Update Posted: November 15, 2006
Last Verified: November 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ACE activity
Fermented milk peptides
Healthy male volunteers

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action