NCT02240264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

2.2 years

First QC Date

September 5, 2014

Last Update Submit

April 5, 2017

Conditions

Cognitive FunctionAcademic PerformanceMental Health

Keywords

Omega-3 fatty acidsCognitive functionAcademic performanceMental healthEye trackingKrill oilLCPUFA

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance

    Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).

    12 months

Secondary Outcomes (4)

  • Eye tracking

    12 months

  • Academic achievement

    12 months

  • Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem

    12 months

  • Sleep duration and sleep quality

    12 months

Study Arms (2)

Krill oil capsules

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Krill oil capsulesDIETARY_SUPPLEMENT

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.

Krill oil capsules
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy adolescents aged 14-15 years.
  • In lower general secondary education (MAVO/VMBO).

You may not qualify if:

  • Suffering from hemophilia (blood clotting disorder).
  • Allergic to (shell)fish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Canisius College

Nijmegen, Gelderland, Netherlands

Location

MAVO Roermond

Roermond, Limburg, Netherlands

Location

De Nassau

Breda, North Brabant, Netherlands

Location

Graaf Engelbrecht

Breda, North Brabant, Netherlands

Location

Newman College

Breda, North Brabant, Netherlands

Location

Dr.Knippenberg College

Helmond, North Brabant, Netherlands

Location

Stabrecht College

Geldrop, Netherlands

Location

Graaf Huyn College

Geleen, Netherlands

Location

Scholengemeenschap Sophianum

Gulpen, Netherlands

Location

Citaverde

Heerlen, Netherlands

Location

Grotius College

Heerlen, Netherlands

Location

Sintermeertencollege

Heerlen, Netherlands

Location

Beroepscollege Holz

Kerkrade, Netherlands

Location

Bouwens van der Boijecollege

Panningen, Netherlands

Location

DaCapo College

Sittard, Netherlands

Location

Stella Maris College

Valkenburg, Netherlands

Location

Colllege Den Hulster

Venlo, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 27401364DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Renate de Groot, PhD

    Open University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Brain, Lifestyle, and Learning Program

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 15, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

August 1, 2016

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

NL(17)