The Effects of Omega-3 Fatty Acids Supplementation on Endothelial Function and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Endothelial Function
研究概览
简要总结
The hypothesis being tested is that in patients with stable claudication and documented PAD, omega-3 supplementation for 1 month will lead to improvement in endothelial function as measured by flow-mediated, brachial artery vasodilation (FMD), as well as improvement in the vascular inflammatory profile as measured by a panel of established circulating inflammatory biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intermittent claudication
- •resting or exercise Ankle-Brachial Index (ABI) <0.9
- •age 50 and more
排除标准
- •critical limb ischemia
- •hypersensitivity/allergies to fish or seafood
- •already on omega-3 fatty acids or equivalent
- •significant renal, hepatic, and inflammatory disease
- •concurrent severe infections
- •acute illness (MI, stroke, major surgery within 30 days)
- •receiving immunosuppressive medications or steroids
研究组 & 干预措施
Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
干预措施: Pro-Omega (Dietary Supplement)
Pro-Omega
High-dose, short-duration dietary omega-3 fatty acids supplementation
干预措施: Omega 3 Fatty Acid (Dietary Supplement)
Placebo
干预措施: Pro-Omega (Dietary Supplement)
Placebo
干预措施: Omega 3 Fatty Acid (Dietary Supplement)
结局指标
主要结局
Endothelial Function
时间窗: 1 month
Flow-mediated, brachial artery vasodilation (FMD)
次要结局
- Inflammatory bio-markers(1 month)