Is Omega-3 Fatty Acid RBC Saturation Product Dependent?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
研究概览
简要总结
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study.
详细描述
To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. The HS-Omega-3 Index is a new test that measures blood levels of the cardioprotective omega-3 fatty acids, EPA and DHA. RBS saturation is being measured to identify how much Omega 3 is in the blood.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give written informed consent.
- •Subject motivation and willingness to cooperate with the investigator by following the required medication regimen.
- •Subject willingness and ability to return for all visits during the study.
- •Must be willing to discontinue all use of Omega-3 supplementation 2 weeks prior to study participation.
排除标准
- •Concurrent involvement in any other clinical trial involving an investigational drug or device.
- •Compromised cognitive ability which may be expected to interfere with study compliance.
- •Uncontrolled or poorly controlled systemic disease ot the presence of any significant illness that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study.
- •Subjects must not eat more that 1 non-fried fish meal per week.
- •Subjects must not have undergone any bariatric surgery or have a malabsorption disorder.
结局指标
主要结局
RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
时间窗: one month
次要结局
- RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.(3 months)