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

2017年4月5日 更新者：Dr. Renate de Groot、Open University

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

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

266

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 荷兰
      • Geldrop、荷兰
        • Stabrecht College
      • Geleen、荷兰
        • Graaf Huyn College
      • Gulpen、荷兰
        • Scholengemeenschap Sophianum
      • Heerlen、荷兰
        • Citaverde
      • Heerlen、荷兰
        • Grotius College
      • Heerlen、荷兰
        • Sintermeertencollege
      • Kerkrade、荷兰
        • Beroepscollege Holz
      • Panningen、荷兰
        • Bouwens van der Boijecollege
      • Sittard、荷兰
        • DaCapo College
      • Valkenburg、荷兰
        • Stella Maris College
      • Venlo、荷兰
        • Colllege Den Hulster
    • Brabant
      • Breda、Brabant、荷兰
        • De Nassau
      • Breda、Brabant、荷兰
        • Graaf Engelbrecht
      • Breda、Brabant、荷兰
        • Newman College
    • Gelderland
      • Nijmegen、Gelderland、荷兰
        • Canisius College
    • Limburg
      • Roermond、Limburg、荷兰
        • MAVO Roermond
    • Noord Brabant
      • Helmond、Noord Brabant、荷兰
        • Dr.Knippenberg College

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 15年 (孩子)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy adolescents aged 14-15 years.
  • In lower general secondary education (MAVO/VMBO).

Exclusion Criteria:

  • Suffering from hemophilia (blood clotting disorder).
  • Allergic to (shell)fish.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
膳食补充剂：Krill oil capsules
1 year supplementation with Krill oil provided by Aker BioMarine Antarctic AS equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.
安慰剂比较：Placebo
Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
膳食补充剂：Placebo
Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Cognitive performance
大体时间：12 months
Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).
12 months

次要结果测量

结果测量
措施说明
大体时间
Eye tracking
大体时间：12 months
Two types of eye tracking parameters will be calculated, namely basic parameters and paragraph-related parameters. Basic parameters are number of blinks, number of fixations, total duration of fixations, average fixation duration, average dispersion of fixation positions, average saccadic amplitude, and average saccadic velocity. Moreover, we will calculate eye tracking measures per paragraph, namely time spent on each paragraph (number and duration of fixations), time elapsed until first looking at a paragraph, and amount of times going back to a paragraph (revisits).
12 months
Academic achievement
大体时间：12 months
Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).
12 months
Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
大体时间：12 months
Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
12 months
Sleep duration and sleep quality
大体时间：12 months
Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Open University

合作者

Netherlands Organisation for Scientific Research
Aker Biomarine Antarctic AS
Omegametrix GmbH
Metrisquare

调查人员

  • 首席研究员：Renate de Groot, PhD、Open University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年1月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年8月1日

研究注册日期

首次提交

2014年9月5日

首先提交符合 QC 标准的

2014年9月12日

首次发布 (估计)

2014年9月15日

研究记录更新

最后更新发布 (实际的)

2017年4月6日

上次提交的符合 QC 标准的更新

2017年4月5日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Food2Learn
  • 13-T-115 (其他标识符：METC Atrium-Orbis-Zuyd)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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