Supplementation With Omega-3: Mechanism of Action
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Fasting triglyceride level
研究概览
简要总结
This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.
详细描述
Observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. However, the mechanisms of action of fish oils are not well understood. Specifically, the effects of different compositions in terms of the ratio of the fatty acids EPA and DHA are not known. We are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high EPA/DHA ratio, high DHA/EPA ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . We will also bank blood and urine for future mechanistic studies. This pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults 20-75 years of age.
- •Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.
排除标准
- •Current user of fish oil supplements
- •Current user of statins
- •Allergy to fish or seafood products
- •Diagnosed/treated diabetes mellitus
- •Using aspirin or NSAIDS or other "blood-thinning medication"
结局指标
主要结局
Fasting triglyceride level
时间窗: 4 weeks
Fasting serum triglyceride levels
次要结局
- Seated blood pressure(4 weeks)
研究者
Dhananjay Vaidya
Associate Professor of Medicine
Johns Hopkins University
