Effect of a Protein Hydrolysate Rich in Lacto-tripeptide (IPP) on Hyperemic Blood Flow and Flow-mediated Dilation in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease
排除标准
- •Treatment with an ACE inhibitor or ARB
- •Pregnancy
- •Other major illness
- •Treatment with an investigational drug within 4 weeks
结局指标
主要结局
Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
时间窗: 12 weeks
次要结局
- Carotid-Femoral Pulse Wave Velocity(12 weeks)
- Leg Reactive Hyperemia(12 weeks)
- Digital Pulse Amplitude Tonometry(12 weeks)
- Blood pressure(12 weeks)
研究者
Joseph A. Vita
Professor of Medicine
Boston University