Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Pa... | NCT00924157

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

NCT00924157

Sponsor

Boston University

Status

Completed

Last Update Posted

May 25, 2012Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

IPP
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 16, 2009

First Submission Date that Met QC Criteria

Jun 17, 2009

First Posted Date

Jun 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2012

Last Update Posted Date

May 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPP	Dietary Supplement	Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
Placebo	Other	Matching placebo capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Carotid-Femoral Pulse Wave Velocity		12 weeks
Leg Reactive Hyperemia		12 weeks
Digital Pulse Amplitude Tonometry

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph A Vita, MD	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston University Medical Center		Boston	Massachusetts	02118	United States

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C041272	indolepropanol phosphate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided