Clinical Trials Directory

Trials / Completed

CompletedNCT02240264

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
266 (actual)
Sponsor
Open University · Academic / Other
Sex
All
Age
13 Years – 15 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKrill oil capsules1 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.
DIETARY_SUPPLEMENTPlaceboCapsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

Timeline

Start date
2014-01-01
Primary completion
2016-03-01
Completion
2016-08-01
First posted
2014-09-15
Last updated
2017-04-06

Locations

17 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02240264. Inclusion in this directory is not an endorsement.