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.

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Mental Health; Academic Performance
• Intervention / Treatment: Dietary supplement: Krill oil capsules; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Geldrop, Netherlands
    • Stabrecht College
  • Geleen, Netherlands
    • Graaf Huyn College
  • Gulpen, Netherlands
    • Scholengemeenschap Sophianum
  • Heerlen, Netherlands
    • Citaverde
  • Heerlen, Netherlands
    • Grotius College
  • Heerlen, Netherlands
    • Sintermeertencollege
  • Kerkrade, Netherlands
    • Beroepscollege Holz
  • Panningen, Netherlands
    • Bouwens van der Boijecollege
  • Sittard, Netherlands
    • DaCapo College
  • Valkenburg, Netherlands
    • Stella Maris College
  • Venlo, Netherlands
    • Colllege Den Hulster
  • Brabant
    • Breda, Brabant, Netherlands
      • De Nassau
    • Breda, Brabant, Netherlands
      • Graaf Engelbrecht
    • Breda, Brabant, Netherlands
      • Newman College
  • Gelderland
    • Nijmegen, Gelderland, Netherlands
      • Canisius College
  • Limburg
    • Roermond, Limburg, Netherlands
      • MAVO Roermond
  • Noord Brabant
    • Helmond, Noord Brabant, Netherlands
      • Dr.Knippenberg College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Krill oil capsules; 1 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.
Placebo Comparator: Placebo; Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.	Dietary supplement: Placebo; Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive performance	Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye tracking	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).	12 months
Academic achievement	Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).	12 months
Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem	Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem	12 months
Sleep duration and sleep quality	Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).	12 months

Collaborators and Investigators

• Sponsor: Open University
• Collaborators: Netherlands Organisation for Scientific Research; Aker Biomarine Antarctic AS; Omegametrix GmbH; Metrisquare
• Investigators: Principal Investigator: Renate de Groot, PhD, Open University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Project page to inform participants and parents/legual guardians.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 12, 2014
• First Posted (Estimate): September 15, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Omega-3 fatty acids; Cognitive function; Mental health; LCPUFA; Academic performance; Eye tracking; Krill oil
• Other Study ID Numbers: Food2Learn; 13-T-115 (Other Identifier: METC Atrium-Orbis-Zuyd)