Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT00924157
First received: June 16, 2009
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected before and after each treatment. The investigators hypothesize that IPP will improve endothelial function.


Condition Intervention
Coronary Artery Disease
Dietary Supplement: IPP
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of a Protein Hydrolysate Rich in Lacto-tripeptide (IPP) on Hyperemic Blood Flow and Flow-mediated Dilation in Patients With Coronary Artery Disease

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid-Femoral Pulse Wave Velocity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Leg Reactive Hyperemia [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Digital Pulse Amplitude Tonometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: IPP
    Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
    Other: Placebo
    Matching placebo capsules
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery disease

Exclusion Criteria:

  • Treatment with an ACE inhibitor or ARB
  • Pregnancy
  • Other major illness
  • Treatment with an investigational drug within 4 weeks
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00924157

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
  More Information

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT00924157     History of Changes
Other Study ID Numbers: H-27820
Study First Received: June 16, 2009
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014