Coronary Artery Disease
Conditions
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.
Interventions
OTHERPlacebo
Matching placebo capsules
DIETARY_SUPPLEMENTIPP
Protein hydrolysate rich in lacto-tripeptide (IPP) up to 5 to 15 mg/day
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Carotid-Femoral Pulse Wave Velocity | 12 weeks |
| Leg Reactive Hyperemia | 12 weeks |
| Digital Pulse Amplitude Tonometry | 12 weeks |
| Blood pressure | 12 weeks |
Countries
United States
Outcome results
None listed