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

NCT ID: NCT00924157

Last Updated: 2012-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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IPP

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Matching placebo capsules

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role lead

Responsible Party

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Joseph A. Vita

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph A Vita, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-27820

Identifier Type: -

Identifier Source: org_study_id

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