Fish Intervention and Learning Abilities in German Youths
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Cognitive Performance
研究概览
简要总结
In the FINS study we test - in a randomized non blinded intervention study- the hypothesis that increased intake of salmon will improve cognitive performance of children aged 4 years to 6 years in the Munich area (Germany), who habitually consume little fish.
详细描述
Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural development during pre- and postnatal development.
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-6 years
排除标准
- •severe illness
- •child dislikes fish
研究组 & 干预措施
Fish Meals
3 Fish meals per week for 4 months
干预措施: Fish Meals (Dietary Supplement)
Placebo
Habitual diet
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Cognitive Performance
时间窗: Change from baseline at 4 months later
次要结局
- Change of iodine levels in urine(Change from baseline at 4 months later)
- Change of cheek cell glycerophospholipids docosahexaenoic and eicosapentaenoic percentage(Change from baseline at 4 months later)
- Change of red blood cell fatty acids (omega-3 index),plasma phospholipid species and plasma vitamin D3(Change from baseline at 4 months later)
研究者
Prof. Berthold Koletzko
Dr med Dr med habil (MD PhD)
Ludwig-Maximilians - University of Munich