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

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ClinicalTrials.gov Identifier: NCT02240264
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : April 6, 2017
Sponsor:
Collaborators:
Netherlands Organisation for Scientific Research
Aker Biomarine Antarctic AS
Omegametrix GmbH
Metrisquare
Information provided by (Responsible Party):
Dr. Renate de Groot, Open University

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.

Condition or disease Intervention/treatment Phase
Cognitive Function Academic Performance Mental Health Dietary Supplement: Krill oil capsules Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

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.



Primary Outcome Measures :
  1. Cognitive performance [ Time Frame: 12 months ]
    Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).


Secondary Outcome Measures :
  1. Eye tracking [ Time Frame: 12 months ]
    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).

  2. Academic achievement [ Time Frame: 12 months ]
    Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).

  3. Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem [ Time Frame: 12 months ]
    Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem

  4. Sleep duration and sleep quality [ Time Frame: 12 months ]
    Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).



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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02240264


Locations
Netherlands
De Nassau
Breda, Brabant, Netherlands
Graaf Engelbrecht
Breda, Brabant, Netherlands
Newman College
Breda, Brabant, Netherlands
Canisius College
Nijmegen, Gelderland, Netherlands
MAVO Roermond
Roermond, Limburg, Netherlands
Dr.Knippenberg College
Helmond, Noord Brabant, Netherlands
Stabrecht College
Geldrop, Netherlands
Graaf Huyn College
Geleen, Netherlands
Scholengemeenschap Sophianum
Gulpen, Netherlands
Citaverde
Heerlen, Netherlands
Grotius College
Heerlen, Netherlands
Sintermeertencollege
Heerlen, Netherlands
Beroepscollege Holz
Kerkrade, Netherlands
Bouwens van der Boijecollege
Panningen, Netherlands
DaCapo College
Sittard, Netherlands
Stella Maris College
Valkenburg, Netherlands
Colllege Den Hulster
Venlo, Netherlands
Sponsors and Collaborators
Open University
Netherlands Organisation for Scientific Research
Aker Biomarine Antarctic AS
Omegametrix GmbH
Metrisquare
Investigators
Principal Investigator: Renate de Groot, PhD Open University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Renate de Groot, Chair Brain, Lifestyle, and Learning Program, Open University
ClinicalTrials.gov Identifier: NCT02240264     History of Changes
Other Study ID Numbers: Food2Learn
13-T-115 ( Other Identifier: METC Atrium-Orbis-Zuyd )
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Keywords provided by Dr. Renate de Groot, Open University:
Omega-3 fatty acids
Cognitive function
Academic performance
Mental health
Eye tracking
Krill oil
LCPUFA