The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People: a Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.
详细描述
The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 elderly people will be randomly allocated to one of three treatments. Two groups will receive fish oil capsules with different doses EPA/DHA (a normal dose or a high dose) and the third group will receive placebo capsules. At the start and at the end of the intervention period cognitive function, the occurrence of depression, quality of life, anthropometric values and biochemical indicators will be measured.
After completion of the trial a workshop will be organized in which the outcomes of the proposed study will be presented to representatives of several key areas concerning mental health of elderly people.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •Aged 65 years and over
- •Informed consent signed
排除标准
- •A score of > 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale
- •A score of < 21 points on MMSE (Mini-Mental State Examination)
- •Current or recent (<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire
- •Current use of pharmacological antidepressants
- •Current use of dementia (Alzheimer) medication
- •Serious liver disease
- •Use of more than 4 glasses of alcohol per day
- •Unable to participate as judged by the responsible medical physician
- •Allergy to fish(oil)
- •Swallowing problems
- •Participation in another clinical trial less than 2 months before the start of the trial or at the same time
结局指标
主要结局
Cognitive function
Depression
次要结局
- Quality of life