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

Not Applicable

Completed

• Conditions: Academic Performance; Cognitive Function; Mental Health
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Krill oil capsules

• 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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
Krill oil capsules	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.

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)

Beroepscollege Holz; 🇳🇱 Kerkrade, Netherlands

MAVO Roermond; 🇳🇱 Roermond, Limburg, Netherlands

De Nassau; 🇳🇱 Breda, Brabant, Netherlands

Scholengemeenschap Sophianum; 🇳🇱 Gulpen, Netherlands

Canisius College; 🇳🇱 Nijmegen, Gelderland, Netherlands

Newman College; 🇳🇱 Breda, Brabant, Netherlands

Citaverde; 🇳🇱 Heerlen, Netherlands

Graaf Engelbrecht; 🇳🇱 Breda, Brabant, Netherlands

Graaf Huyn College; 🇳🇱 Geleen, Netherlands

Sintermeertencollege; 🇳🇱 Heerlen, Netherlands

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

Stabrecht College; 🇳🇱 Geldrop, Netherlands

Bouwens van der Boijecollege; 🇳🇱 Panningen, Netherlands

DaCapo College; 🇳🇱 Sittard, Netherlands

Grotius College; 🇳🇱 Heerlen, Netherlands

Stella Maris College; 🇳🇱 Valkenburg, Netherlands

Colllege Den Hulster; 🇳🇱 Venlo, Netherlands