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| ID | Type | Description | Link |
|---|---|---|---|
| 13-T-115 | Other Identifier | METC Atrium-Orbis-Zuyd |
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| Name | Class |
|---|---|
| Netherlands Organisation for Scientific Research | OTHER_GOV |
| Aker BioMarine Human Ingredients AS | INDUSTRY |
| Omegametrix GmbH | UNKNOWN |
| Metrisquare |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo | Placebo Comparator | Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Krill oil capsules | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive performance | Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span). | 12 months |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renate de Groot, PhD | Open University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius College | Nijmegen | Gelderland | Netherlands | |||
| MAVO Roermond |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27401364 | Derived | 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. |
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| UNKNOWN |
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| Placebo | Dietary Supplement | Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet. |
|
| 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 |
| Roermond |
| Limburg |
| Netherlands |
| De Nassau | Breda | North Brabant | Netherlands |
| Graaf Engelbrecht | Breda | North Brabant | Netherlands |
| Newman College | Breda | North Brabant | Netherlands |
| Dr.Knippenberg College | Helmond | North 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 |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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