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van CCT (UK)

van CCT (UK)

Food2Learn: Effect of omega-3 LCPUFA intervention on learning, cognition, behaviour and visual processing

- candidate number15155
- NTR NumberNTR4082
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2013
- Secondary IDs13-T-115 METC
- Public TitleFood2Learn: Effect of omega-3 LCPUFA intervention on learning, cognition, behaviour and visual processing
- Scientific TitleFood2Learn: Effect of omega-3 LCPUFA intervention on learning, cognition, behaviour and visual processing
- ACRONYMFood2Learn
- hypothesisSupplementation with omega-3 LCPUFA from krill oil in healthy adolescents will result in:
- improvement of the omega-3 index
- improved cognitive performance
- improved mental well-being
- better academic achievement
- Healt Condition(s) or Problem(s) studiedOmega-3 fatty acids, Cognition, Schoolperformance, Mental health, Eye movements, Krill oil, LCPUFA
- Inclusion criteriaHealthy adolescents aged 14-15 years in lower general secondary education (MAVO/VMBO).
- Exclusion criteriaSuffering from any medical disorders associated with learning deficits, such as ADHD, dyslexia, or autism.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate31-dec-2017
- Target number of participants350
- Interventions1 years supplementation with Krill oil provided by Aker BioMarine Antarctic AS and Olympic seafood equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.
- Primary outcomeAcademic achievement: grade point average for Dutch, English, and Mathematics
Cognitive performance: neuropsychological tests covering several executive functions (SDMT, D2, N-back, CST)
Behavior: absenteeism, motivation (MSLQ), goal orientation (AGQ), Mood (CES-D), Self-esteem (RSE)
- Secondary outcomeTwo 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).
- TimepointsBaseline and follow up after 3 months, 6 months, and 12 months. Intervention of another 12 months (up to 24 months) is still under consideration.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Open University the Netherlands
- Funding
(Source(s) of Monetary or Material Support)
NWO, Aker BioMarine Antarctic AS, Olympic Seafood, Metrisquare B.V., Omegametrix
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD18-jul-2013 - 11-feb-2014

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