- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02240264
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Geldrop, Holland
- Stabrecht College
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Geleen, Holland
- Graaf Huyn College
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Gulpen, Holland
- Scholengemeenschap Sophianum
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Heerlen, Holland
- Citaverde
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Heerlen, Holland
- Grotius College
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Heerlen, Holland
- Sintermeertencollege
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Kerkrade, Holland
- Beroepscollege Holz
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Panningen, Holland
- Bouwens van der Boijecollege
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Sittard, Holland
- DaCapo College
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Valkenburg, Holland
- Stella Maris College
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Venlo, Holland
- Colllege Den Hulster
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Brabant
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Breda, Brabant, Holland
- De Nassau
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Breda, Brabant, Holland
- Graaf Engelbrecht
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Breda, Brabant, Holland
- Newman College
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Gelderland
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Nijmegen, Gelderland, Holland
- Canisius College
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Limburg
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Roermond, Limburg, Holland
- MAVO Roermond
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Noord Brabant
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Helmond, Noord Brabant, Holland
- Dr.Knippenberg College
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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. |
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.
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Placebo komparator: Placebo
Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
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Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cognitive performance
Tidsramme: 12 months
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Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Eye tracking
Tidsramme: 12 months
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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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12 months
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Academic achievement
Tidsramme: 12 months
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Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).
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12 months
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Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
Tidsramme: 12 months
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Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
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12 months
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Sleep duration and sleep quality
Tidsramme: 12 months
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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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12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Renate de Groot, PhD, Open University
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Food2Learn
- 13-T-115 (Anden identifikator: METC Atrium-Orbis-Zuyd)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Kliniske forsøg med Krill oil capsules
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University of GlasgowAktiv, ikke rekrutterendeEn sammenligning af virkningerne af krillolie og fiskeolietilskud på muskelfunktion hos ældre voksneSarkopeniDet Forenede Kongerige
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Baskent UniversityAfsluttet
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Supplement Formulators, Inc.AfsluttetBetændelseForenede Stater
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Supplement Formulators, Inc.AfsluttetBetændelse | Inflammatorisk responsForenede Stater
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Universiti Sains MalaysiaAfsluttet
-
Galderma R&DAfsluttet
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CalanusBiofortis Clinical Research, Inc.AfsluttetSund og raskForenede Stater
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Danbury HospitalPrograde NutritionAfsluttetType II diabetes mellitusForenede Stater
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SeppicAfsluttet
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SeppicAfsluttetSunde frivilligeItalien