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

Inge Van der Wurff, Clemens Von Schacky, Kjetil Berge, Paul A. Kirschner, Renate De Groot

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Abstract

Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (LCPUFA) supplementation on brain functioning is debated. Some studies have found positive effects on cognition in children with learning difficulties, elderly people with cognitive impairment and depression scores in depressed individuals. Other studies have found null or negative effects. Observational studies in adolescents have found positive associations between fish consumption (containing n-3 LCPUFAs) and academic achievement. However, intervention studies in typically developing adolescents are missing. Objective: The goal of this study is to determine the influence of increasing Omega-3 Index on cognitive functioning, academic achievement and mental wellbeing of typically developing adolescents. Methods and data analysis: Double-blind, randomised, placebo controlled intervention; 264 adolescents (age 13–15 years) attending lower general secondary education started daily supplementation of 400 mg eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) in cohort I (n=130) and 800 mg EPA +DHA in cohort II (n=134) or a placebo for 52 weeks. Recruitment took place according to a low Omega-3 Index (<5%). The Omega-3 Index was monitored via a finger prick at baseline and after 3, 6 and 12 months. The supplement dose was adjusted after 3 months (placebo analogously) to reach an Omega-3 Index of 8–11%. At baseline, 6 and 12 months, a neuropsychological test battery, a number of questionnaires and a standardised math test (baseline and 12 months) were administered. School grades were collected. In a subsample, sleep quality and quantity data (n=64) and/or eye-tracking data (n=33) were collected. Ethics and dissemination: Food2Learn is performed according to Good Clinical Practice. All data collected are linked to participant number only. The results will be disseminated on group level to participants and schools. The results will be presented at conferences and published in peer-reviewed journals. The study is approved by the Medical Ethical Committee of Atrium-Orbis-Zuyd Hospital and is registered at the Netherlands Trial Register (NTR4082). Trial registration numbers: NTR4082 and NCT02240264; Pre-results.
Original languageEnglish
JournalBMJ Open
Volume6
Issue number7
DOIs
Publication statusPublished - 8 Jul 2016

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Euphausiacea
Cognition
Oils
Randomized Controlled Trials
Placebos
Learning
Eicosapentaenoic Acid
Docosahexaenoic Acids
Neuropsychological Tests
Unsaturated Fatty Acids
Ethics
Netherlands
Fingers
Observational Studies
Sleep
Fishes
Depression
Education
Brain

Keywords

  • nutrition
  • brain
  • adolescents
  • cognition
  • long-chain polyunsaturated fatty acids

Cite this

@article{17b66978b8004357a8fc181b11168e0d,
title = "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",
abstract = "Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (LCPUFA) supplementation on brain functioning is debated. Some studies have found positive effects on cognition in children with learning difficulties, elderly people with cognitive impairment and depression scores in depressed individuals. Other studies have found null or negative effects. Observational studies in adolescents have found positive associations between fish consumption (containing n-3 LCPUFAs) and academic achievement. However, intervention studies in typically developing adolescents are missing. Objective: The goal of this study is to determine the influence of increasing Omega-3 Index on cognitive functioning, academic achievement and mental wellbeing of typically developing adolescents. Methods and data analysis: Double-blind, randomised, placebo controlled intervention; 264 adolescents (age 13–15 years) attending lower general secondary education started daily supplementation of 400 mg eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) in cohort I (n=130) and 800 mg EPA +DHA in cohort II (n=134) or a placebo for 52 weeks. Recruitment took place according to a low Omega-3 Index (<5{\%}). The Omega-3 Index was monitored via a finger prick at baseline and after 3, 6 and 12 months. The supplement dose was adjusted after 3 months (placebo analogously) to reach an Omega-3 Index of 8–11{\%}. At baseline, 6 and 12 months, a neuropsychological test battery, a number of questionnaires and a standardised math test (baseline and 12 months) were administered. School grades were collected. In a subsample, sleep quality and quantity data (n=64) and/or eye-tracking data (n=33) were collected. Ethics and dissemination: Food2Learn is performed according to Good Clinical Practice. All data collected are linked to participant number only. The results will be disseminated on group level to participants and schools. The results will be presented at conferences and published in peer-reviewed journals. The study is approved by the Medical Ethical Committee of Atrium-Orbis-Zuyd Hospital and is registered at the Netherlands Trial Register (NTR4082). Trial registration numbers: NTR4082 and NCT02240264; Pre-results.",
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author = "{Van der Wurff}, Inge and {Von Schacky}, Clemens and Kjetil Berge and Kirschner, {Paul A.} and {De Groot}, Renate",
year = "2016",
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language = "English",
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T1 - 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

AU - Van der Wurff, Inge

AU - Von Schacky, Clemens

AU - Berge, Kjetil

AU - Kirschner, Paul A.

AU - De Groot, Renate

PY - 2016/7/8

Y1 - 2016/7/8

N2 - Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (LCPUFA) supplementation on brain functioning is debated. Some studies have found positive effects on cognition in children with learning difficulties, elderly people with cognitive impairment and depression scores in depressed individuals. Other studies have found null or negative effects. Observational studies in adolescents have found positive associations between fish consumption (containing n-3 LCPUFAs) and academic achievement. However, intervention studies in typically developing adolescents are missing. Objective: The goal of this study is to determine the influence of increasing Omega-3 Index on cognitive functioning, academic achievement and mental wellbeing of typically developing adolescents. Methods and data analysis: Double-blind, randomised, placebo controlled intervention; 264 adolescents (age 13–15 years) attending lower general secondary education started daily supplementation of 400 mg eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) in cohort I (n=130) and 800 mg EPA +DHA in cohort II (n=134) or a placebo for 52 weeks. Recruitment took place according to a low Omega-3 Index (<5%). The Omega-3 Index was monitored via a finger prick at baseline and after 3, 6 and 12 months. The supplement dose was adjusted after 3 months (placebo analogously) to reach an Omega-3 Index of 8–11%. At baseline, 6 and 12 months, a neuropsychological test battery, a number of questionnaires and a standardised math test (baseline and 12 months) were administered. School grades were collected. In a subsample, sleep quality and quantity data (n=64) and/or eye-tracking data (n=33) were collected. Ethics and dissemination: Food2Learn is performed according to Good Clinical Practice. All data collected are linked to participant number only. The results will be disseminated on group level to participants and schools. The results will be presented at conferences and published in peer-reviewed journals. The study is approved by the Medical Ethical Committee of Atrium-Orbis-Zuyd Hospital and is registered at the Netherlands Trial Register (NTR4082). Trial registration numbers: NTR4082 and NCT02240264; Pre-results.

AB - Introduction: The influence of n-3 long-chain polyunsaturated fatty acids (LCPUFA) supplementation on brain functioning is debated. Some studies have found positive effects on cognition in children with learning difficulties, elderly people with cognitive impairment and depression scores in depressed individuals. Other studies have found null or negative effects. Observational studies in adolescents have found positive associations between fish consumption (containing n-3 LCPUFAs) and academic achievement. However, intervention studies in typically developing adolescents are missing. Objective: The goal of this study is to determine the influence of increasing Omega-3 Index on cognitive functioning, academic achievement and mental wellbeing of typically developing adolescents. Methods and data analysis: Double-blind, randomised, placebo controlled intervention; 264 adolescents (age 13–15 years) attending lower general secondary education started daily supplementation of 400 mg eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA) in cohort I (n=130) and 800 mg EPA +DHA in cohort II (n=134) or a placebo for 52 weeks. Recruitment took place according to a low Omega-3 Index (<5%). The Omega-3 Index was monitored via a finger prick at baseline and after 3, 6 and 12 months. The supplement dose was adjusted after 3 months (placebo analogously) to reach an Omega-3 Index of 8–11%. At baseline, 6 and 12 months, a neuropsychological test battery, a number of questionnaires and a standardised math test (baseline and 12 months) were administered. School grades were collected. In a subsample, sleep quality and quantity data (n=64) and/or eye-tracking data (n=33) were collected. Ethics and dissemination: Food2Learn is performed according to Good Clinical Practice. All data collected are linked to participant number only. The results will be disseminated on group level to participants and schools. The results will be presented at conferences and published in peer-reviewed journals. The study is approved by the Medical Ethical Committee of Atrium-Orbis-Zuyd Hospital and is registered at the Netherlands Trial Register (NTR4082). Trial registration numbers: NTR4082 and NCT02240264; Pre-results.

KW - nutrition

KW - brain

KW - adolescents

KW - cognition

KW - long-chain polyunsaturated fatty acids

U2 - 10.1136/bmjopen-2016-011790

DO - 10.1136/bmjopen-2016-011790

M3 - Article

VL - 6

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 7

ER -