Clinical trial NCT02240264: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.
Official title: Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Academic Performance
Mental Health
Keywords: Omega-3 fatty acids
Cognitive function
Academic performance
Mental health
Eye tracking
Krill oil
LCPUFA
Lead sponsor: Open University
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: Aker BioMarine Human Ingredients AS
name: Omegametrix GmbH
name: Metrisquare
First posted: 2014-09-15
Enrollment: 266
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive performance
timeFrame: 12 months
Secondary outcomes:
measure: Eye tracking
timeFrame: 12 months
measure: Academic achievement
timeFrame: 12 months
measure: Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
timeFrame: 12 months
measure: Sleep duration and sleep quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: De Nassau
state: Brabant
city: Breda
country: Netherlands
facility: Graaf Engelbrecht
state: Brabant
city: Breda
country: Netherlands
facility: Newman College
state: Brabant
city: Nijmegen
country: Netherlands
facility: Canisius College
state: Gelderland
city: Roermond
country: Netherlands
facility: MAVO Roermond
state: Limburg
city: Helmond
country: Netherlands
facility: Dr.Knippenberg College
state: Noord Brabant
city: Geldrop
country: Netherlands
facility: Stabrecht College
city: Geleen
country: Netherlands
facility: Graaf Huyn College
city: Gulpen
country: Netherlands
facility: Scholengemeenschap Sophianum
city: Heerlen
country: Netherlands
facility: Citaverde
city: Heerlen
country: Netherlands
facility: Grotius College
city: Heerlen
country: Netherlands
facility: Sintermeertencollege
city: Kerkrade
country: Netherlands
facility: Beroepscollege Holz
city: Panningen
country: Netherlands
facility: Bouwens van der Boijecollege
city: Sittard
country: Netherlands
facility: DaCapo College
city: Valkenburg
country: Netherlands
facility: Stella Maris College
city: Venlo
country: Netherlands
facility: Colllege Den Hulster
Study officials:
affiliation: Open University
name: Renate de Groot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Wurff IS, von Schacky C, Berge K, Kirschner PA, de Groot RH. A protocol for a randomised controlled trial investigating the effect of increasing Omega-3 index with krill oil supplementation on learning, cognition, behaviour and visual processing in typically developing adolescents. BMJ Open. 2016 Jul 8;6(7):e011790. doi: 10.1136/bmjopen-2016-011790.