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Completed

NCT Number: NCT02240264

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.

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Key information

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canisius College, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Krill oil capsules

Dietary Supplement

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.

Placebo

Dietary Supplement

Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

Primary outcomes

  1. Cognitive performance

    Time frame: 12 months

    Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).

Secondary outcomes

  1. Eye tracking

    Time frame: 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).

  2. Academic achievement

    Time frame: 12 months

    Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).

  3. Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem

    Time frame: 12 months

    Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem

  4. Sleep duration and sleep quality

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Open University

Other

Collaborators

  • Aker BioMarine Human Ingredients AS
  • Metrisquare
  • Netherlands Organisation for Scientific Research
  • Omegametrix GmbH

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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