NCT00924157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 25, 2012

Status Verified

May 1, 2012

Enrollment Period

2.8 years

First QC Date

June 16, 2009

Last Update Submit

May 23, 2012

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia

    12 weeks

Secondary Outcomes (4)

  • Carotid-Femoral Pulse Wave Velocity

    12 weeks

  • Leg Reactive Hyperemia

    12 weeks

  • Digital Pulse Amplitude Tonometry

    12 weeks

  • Blood pressure

    12 weeks

Interventions

IPPDIETARY_SUPPLEMENT

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

PlaceboOTHER

Matching placebo capsules

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary artery disease

You may not qualify if:

  • Treatment with an ACE inhibitor or ARB
  • Pregnancy
  • Other major illness
  • Treatment with an investigational drug within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

indolepropanol phosphate

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Joseph A Vita, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 18, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 25, 2012

Record last verified: 2012-05

Locations

US(1)