Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- primary psychometric assessment battery
研究概览
简要总结
Stress-related disorders are among the most prevalent and expensive medical consequences of participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are known to benefit both neuronal development in the young, and cognition and mood in various populations.
It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher cognitive performance, better affect/mood state, and less combat stress symptomatology compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the prevalence of combat stress injuries in military personnel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •US Army deployed personnel
- •score on a mood questionnaire
排除标准
- •currently consume omega-3 fish oil supplements
- •are currently taking antidepressant or other medications for psychiatric purposes
- •known fish or shellfish allergy
研究组 & 干预措施
Lovaza, omega-3 fatty acid ethyl ester
干预措施: Lovaza, omega-3 fatty acid ethyl ester (Drug)
Placebo
one gram corn oil in a soft gelatin capsule
干预措施: Placebo, visually identical to Lovaza (Drug)
结局指标
主要结局
primary psychometric assessment battery
时间窗: 3 months
Specific components include: Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
omega-3 fatty acid status
时间窗: 3 months
finger-prick blood spot is collected for determination of fatty acid composition and profile.
次要结局
- secondary psychometric assessment battery(3 months)