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

Healthy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399737
• Other study ID #: NU167
• Status: Terminated
• Phase: Phase 1
• First received: November 14, 2006
• Last updated: November 14, 2006
• Start date: October 2005
• Est. completion date: November 2005

Study information

• Verified date: November 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers

• aged between 18 and 35 years

• informed written consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Clinical Investigation Center 920, Hôpital Européen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Danone Institute International

Country where clinical trial is conducted

France, 

References & Publications (1)

FitzGerald RJ, Murray BA, Walsh DJ. Hypotensive peptides from milk proteins. J Nutr. 2004 Apr;134(4):980S-8S. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACE activity
Secondary	kinetics/dynamics