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Cognitive FunctionNCT02240264

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

A study testing Krill oil capsules in people with Cognitive Function and Academic Performance, run by Open University at 17 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 15 yearsHealthy volunteers can take part
What is being tested?
Krill oil capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
266 participants
Where
17 sitesNetherlands
Study dates
Jan 2014to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Netherlands17 sites

  • De Nassau

    Breda, North Brabant

  • Graaf Engelbrecht

    Breda, North Brabant

  • Newman College

    Breda, North Brabant

  • Stabrecht College

    Geldrop

  • Graaf Huyn College

    Geleen

  • Scholengemeenschap Sophianum

    Gulpen

  • Citaverde

    Heerlen

  • Grotius College

    Heerlen

  • Sintermeertencollege

    Heerlen

  • Dr.Knippenberg College

    Helmond, North Brabant

  • Beroepscollege Holz

    Kerkrade

  • Canisius College

    Nijmegen, Gelderland

  • Bouwens van der Boijecollege

    Panningen

  • MAVO Roermond

    Roermond, Limburg

  • DaCapo College

    Sittard

  • Stella Maris College

    Valkenburg

  • Colllege Den Hulster

    Venlo

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Krill oil capsules, Placebo
Keywords
Omega-3 fatty acids, Cognitive function, Academic performance, Mental health, Eye tracking, Krill oil, LCPUFA
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDietary supplement

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

Study groups in NCT02240264
Study groupRoleWhat they receive
Krill oil capsulesActive comparatorCapsules 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.
Receives: Dietary Supplement: Krill oil capsules
PlaceboPlacebo comparatorCapsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive performance

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

    Measured: 12 months

Secondary outcomes (4)

  1. 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).

    Measured: 12 months

  2. Academic achievement

    Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).

    Measured: 12 months

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

    Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem

    Measured: 12 months

  4. 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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240264
Sponsor's protocol ID
Food2Learn
Other IDs
13-T-115
Status last verified
Apr 2017
First submitted
5 Sep 2014
Last updated
6 Apr 2017
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 27401364

Questions about this trial

What is this clinical trial studying?

A study testing Krill oil capsules in people with Cognitive Function and Academic Performance, run by Open University at 17 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive performance (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240264, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.

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