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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014