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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924157
• Other study ID #: H-27820
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: May 23, 2012
• Start date: July 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Dietary Supplement:
• IPP
Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day

Other:
• Placebo
Matching placebo capsules

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia		12 weeks	No
Secondary	Carotid-Femoral Pulse Wave Velocity		12 weeks	No
Secondary	Leg Reactive Hyperemia		12 weeks	No
Secondary	Digital Pulse Amplitude Tonometry		12 weeks	No
Secondary	Blood pressure		12 weeks	No