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临床试验/NCT02240264
NCT02240264已完成不适用

Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.

Open University17 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Placebo Comparator

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

发起方
Open University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Renate de Groot

Chair Brain, Lifestyle, and Learning Program

Open University

研究点 (17)

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