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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00924157
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Study Start: 2009-07
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia	12 weeks

Secondary Outcome Measures

Name	Time	Method
Carotid-Femoral Pulse Wave Velocity	12 weeks
Leg Reactive Hyperemia	12 weeks
Digital Pulse Amplitude Tonometry	12 weeks
Blood pressure	12 weeks

Trial Locations

Locations (1)

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States