The Effects of Omega-3 Fatty Acids Dietary Supplements (Fish-oil) on Mood and Cognitive Functions of Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Cognition
研究概览
简要总结
The investigators recently found a positive effect of omega-3 supplements on cognitive function in healthy individuals after 4 weeks (J of Psychopharmacology 2009, 23: 831-840). The investigators hypothesize that 4 weeks consumption of omega-3 supplements in previously depressed individuals will positively affect their cognitive functions.
Secondly, low Heart Rate Variability (HRV) is a risk factor for cardiovascular disease. Some studies have found low HRV in patients with depression. No studies have investigated the effects of omega-3 fatty acid supplements on Heart Rate Variability in individuals with a history of depression. The investigators will test the hypotheses that omega-3 supplements lead to an improvement of heart rate variability indices in healthy volunteers with a history of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dutch-speaking men and women
- •Normal weight (BMI between 18 and 27).
- •Regular diets, not containing fish more than once a week.
- •History of depression (at least one major depressive episode in the past).
排除标准
- •Currently more than mildly depressed (BDI-II-NL score higher than 19, or score on the suicidality item of this scale higher than 1).
- •Current or past psychosis
- •Current substance abuse or past substance dependence
- •Smoking or current use of soft drugs (current = month prior to study till completion)
- •Any hard drug use (lifetime)
- •More than 3 alcoholic consumptions/day
- •Participants will be asked to keep their dietary habits constant throughout the study.
结局指标
主要结局
Cognition
时间窗: 4 weeks
Battery of test measuring emotional and neutral information processing. Largest effect expected on Decision Making Test (cf. Antypa et al., 2009) and Emotion Recognition Test.
Heart Rate Variability
时间窗: 4 weeks
次要结局
- Mood states(4 weeks)