Back to resultsEffect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPP
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Boston University Medical Center
Outcomes
Primary Outcome Measures
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
Secondary Outcome Measures
Carotid-Femoral Pulse Wave Velocity
Leg Reactive Hyperemia
Digital Pulse Amplitude Tonometry
Blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00924157
Brief Title
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
IPP
Intervention Description
Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsules
Primary Outcome Measure Information:
Title
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Carotid-Femoral Pulse Wave Velocity
Time Frame
12 weeks
Title
Leg Reactive Hyperemia
Time Frame
12 weeks
Title
Digital Pulse Amplitude Tonometry
Time Frame
12 weeks
Title
Blood pressure
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Vita, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
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