NCT00399737

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
Last Updated

November 15, 2006

Status Verified

November 1, 2006

First QC Date

November 14, 2006

Last Update Submit

November 14, 2006

Conditions

Healthy

Keywords

ACE activityFermented milk peptidesHealthy male volunteers

Outcome Measures

Primary Outcomes (1)

  • ACE activity

Secondary Outcomes (1)

  • kinetics/dynamics

Interventions

repeated intake of fermented milk followed by a single oral dose of an ACE inhibitorDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers
  • aged between 18 and 35 years
  • informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center 920, Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

  • FitzGerald RJ, Murray BA, Walsh DJ. Hypotensive peptides from milk proteins. J Nutr. 2004 Apr;134(4):980S-8S. doi: 10.1093/jn/134.4.980S.

    PMID: 15051858RESULT

Study Officials

  • Michel Azizi

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

October 1, 2005

Study Completion

November 1, 2005

Last Updated

November 15, 2006

Record last verified: 2006-11

Locations

FR(1)