Effects of Peptides Derived From Fermented Milk on Blood... | NCT00399737

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

NCT00399737

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Terminated

Last Update Posted

Nov 15, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Healthy

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Nov 14, 2006

First Submission Date that Met QC Criteria

Nov 14, 2006

First Posted Date

Nov 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2006

Last Update Posted Date

Nov 15, 2006Estimated

Name	Class
Danone Institute International	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
repeated intake of fermented milk followed by a single oral dose of an ACE inhibitor	Drug

Measure	Description	Time Frame
ACE activity

Measure	Description	Time Frame
kinetics/dynamics

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel Azizi	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Investigation Center 920, Hôpital Européen Georges Pompidou		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15051858	Result	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.