A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in Omega-3 index
研究概览
简要总结
The study determines the EPA DHA uptake from different omega-3 supplements against a control.
详细描述
The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women, ≥18 -65 years of age.
- •Willing to refrain from taking omega-3 supplements for 1 month prior to study start
- •Willing to take study supplement for 2 months
排除标准
- •Subjects with known allergy to fish products
- •Subjects known to be pregnant or breast feeding
结局指标
主要结局
Change in Omega-3 index
时间窗: Baseline (supplementation start: time point 0) to 2 months of supplementation
Change in the omega-3 index (EPA and DHA content as a % of total fatty acids in red blood cells) from baseline to end of supplementation
次要结局
- Change in fatty acid profile from baseline to end of supplementation between study arms.(Baseline to 2 months of supplementation.)