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

This study has been terminated.
Sponsor:
Collaborator:
Danone Institute International
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00399737
First received: November 14, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 14, 2006
Last Updated: November 14, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014