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Completed

NCT Number: NCT00924157

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPP

Dietary Supplement

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

Placebo

Other

Matching placebo capsules

Primary outcomes

  1. Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia

    Time frame: 12 weeks

Secondary outcomes

  1. Carotid-Femoral Pulse Wave Velocity

    Time frame: 12 weeks

  2. Leg Reactive Hyperemia

    Time frame: 12 weeks

  3. Digital Pulse Amplitude Tonometry

    Time frame: 12 weeks

  4. Blood pressure

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2009
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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