Field Trial With Omega-3 Fatty Acid Supplementation for the Prevention of Cognitive Decline in a Very Elderly Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- Mini Mental State Examination
研究概览
简要总结
The purpose of this study is to determine whether an omega-3 fatty acid supplementation is effective in the prevention of progressive cognitive decline in elderly people aged 75 years or older.
详细描述
Participants are residents at three nursing homes in Pamplona (Spain). We assumed that 20% of elderly people have a cognitive decline and we estimated a 5% of cognitive decline in the intervention group. Sample size estimated was 85 participants for each arm, assuming two groups with an alpha of 0.05, 80% power and accounting for 10% of participants lost to follow-up.
Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used for the statistical analysis of data.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly people aged 75 years or older
- •Global Deterioration Scale < 4
- •Capacity to complete the tests
排除标准
- •Neurological, physical or psychiatry conditions, obtained from the medical history, that may have an influence on the cognitive function.
- •History of epilepsy, convulsions
结局指标
主要结局
Mini Mental State Examination
时间窗: Six months / one year
MMSE is a brief questionnaire test that is used to screen for cognitive impairment. A validated test in Spanish will be used: Lobo A. Saza P. Marcos G, Díaz J, De la Cámara C, Ventura T et al: Revalidación y normalización del Mini-Examen Cogniscitivo (primera versión en castellano del Mini-Mental Status Examination) en la población general geriátrica. Med Clin (Barc) 1999;112:767-774.
次要结局
- Short Portable Mental Status Questionnaire (SPMSQ)(One year)
- Clock-drawing test(One year)
- Verbal fluency test(One year)