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

Not Applicable

Completed

• Conditions: Academic Performance; Cognitive Function; Mental Health

• Registration Number: NCT02240264
• Lead Sponsor: Open University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-15
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive performance	12 months	Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).

Secondary Outcome Measures

Name	Time	Method
Eye tracking	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).
Academic achievement	12 months	Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).
Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem	12 months	Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
Sleep duration and sleep quality	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).

Trial Locations

Locations (17)

De Nassau; 🇳🇱 Breda, Brabant, Netherlands

Graaf Engelbrecht; 🇳🇱 Breda, Brabant, Netherlands

Newman College; 🇳🇱 Breda, Brabant, Netherlands

Canisius College; 🇳🇱 Nijmegen, Gelderland, Netherlands

MAVO Roermond; 🇳🇱 Roermond, Limburg, Netherlands

Dr.Knippenberg College; 🇳🇱 Helmond, Noord Brabant, Netherlands

Stabrecht College; 🇳🇱 Geldrop, Netherlands

Graaf Huyn College; 🇳🇱 Geleen, Netherlands

Scholengemeenschap Sophianum; 🇳🇱 Gulpen, Netherlands

Citaverde; 🇳🇱 Heerlen, Netherlands

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