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

Open University

Status: Completed

Conditions: Cognitive Function; Mental Health; Academic Performance

Treatments: Dietary Supplement: Krill oil capsules; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02240264

Food2Learn

13-T-115 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 266 patients

Sex: All

Ages: 13 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups, including a placebo group

Krill oil capsules

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Krill oil capsules

Placebo

Placebo Comparator group

Description:

Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

Treatment:

Dietary Supplement: Placebo