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

Sponsors

Lead sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator: Danone Institute International

Source Assistance Publique - Hôpitaux de Paris
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.

Overall Status Terminated
Start Date October 2005
Completion Date November 2005
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
ACE activity
Secondary Outcome
Measure Time Frame
kinetics/dynamics
Enrollment 12
Condition
Intervention

Intervention type: Drug

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

Eligibility

Criteria:

Inclusion Criteria:

- Healthy male volunteers

- aged between 18 and 35 years

- informed written consent

Gender: Male

Minimum age: 18 Years

Maximum age: 35 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michel Azizi Principal Investigator APHP
Location
facility Clinical Investigation Center 920, Hôpital Européen Georges Pompidou
Location Countries

France

Verification Date

November 2006

Keywords
Has Expanded Access No
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov