跳至主要内容
临床试验/NCT02036307
NCT02036307终止2 期

Supplementation With Omega-3: Mechanism of Action

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dhananjay Vaidya

Associate Professor of Medicine

Johns Hopkins University

研究点 (2)

Loading locations...

相似试验

Supplementation With Omega-3: Mechanism of Action | 临床试验