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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00924157
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
Joseph A. Vita, Boston University

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Dietary Supplement: IPP Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Dietary Supplement: IPP
    Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
    Other: Placebo
    Matching placebo capsules

Primary Outcome Measures :
  1. Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Carotid-Femoral Pulse Wave Velocity [ Time Frame: 12 weeks ]
  2. Leg Reactive Hyperemia [ Time Frame: 12 weeks ]
  3. Digital Pulse Amplitude Tonometry [ Time Frame: 12 weeks ]
  4. Blood pressure [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00924157

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

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University Identifier: NCT00924157     History of Changes
Other Study ID Numbers: H-27820
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

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