Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 17
- 主要终点
- Cognitive performance
研究概览
简要总结
The brain is primarily developed in the third trimester of pregnancy, but continues maturing through the late twenties, especially the prefrontal cortex. Omega-3 long-chain polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell membranes, influence membrane fluidity and signal transduction, and thus learning, cognition and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with limitations in these complex brain functions. Previous studies suggested that such functions could be improved by increasing LCPUFA. The adolescent brain, however, has been largely neglected. This study investigates the effect of one-year daily omega-3 LCPUFA supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be adjusted individually to reach a target level of 8-11%. The effects on learning (academic achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation, goal-orientation, absenteeism), and in a subsample cognitive processes, in particular perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months. This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a safe intervention, on a large variety of complex brain functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents aged 14-15 years.
- •In lower general secondary education (MAVO/VMBO).
排除标准
- •Suffering from hemophilia (blood clotting disorder).
- •Allergic to (shell)fish.
研究组 & 干预措施
Krill oil capsules
Capsules containing krill oil rich in omega-3 fatty acid's.
Dietary supplements (krill oil) are provided by Aker BioMarine Antarctic AS equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.
Addendum 25-4-2016: In the Original protocol a dose adjustment after 3 months according to Omega-3 Index was to be executed. As no participant achieved the target Omega-3 Index the dosage was adjusted to 800mg DHA + EPA per day for all participants. The also led to the decision to increase the starting dosage of cohort II to 800mg DHA+ EPA.
干预措施: Krill oil capsules (Dietary Supplement)
Placebo
Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Cognitive performance
时间窗: 12 months
Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).
次要结局
- Eye tracking(12 months)
- Academic achievement(12 months)
- Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem(12 months)
- Sleep duration and sleep quality(12 months)
研究者
Dr. Renate de Groot
Chair Brain, Lifestyle, and Learning Program
Open University
