<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02240264</url>
  </required_header>
  <id_info>
    <org_study_id>Food2Learn</org_study_id>
    <secondary_id>13-T-115</secondary_id>
    <nct_id>NCT02240264</nct_id>
  </id_info>
  <brief_title>Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.</brief_title>
  <official_title>Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Open University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Netherlands Organisation for Scientific Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aker Biomarine Antarctic AS</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Omegametrix GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Metrisquare</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Open University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The brain is primarily developed in the third trimester of pregnancy, but continues maturing&#xD;
      through the late twenties, especially the prefrontal cortex. Omega-3 long-chain&#xD;
      polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell&#xD;
      membranes, influence membrane fluidity and signal transduction, and thus learning, cognition&#xD;
      and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with&#xD;
      limitations in these complex brain functions. Previous studies suggested that such functions&#xD;
      could be improved by increasing LCPUFA. The adolescent brain, however, has been largely&#xD;
      neglected. This study investigates the effect of one-year daily omega-3 LCPUFA&#xD;
      supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower&#xD;
      general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority&#xD;
      of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake&#xD;
      of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents&#xD;
      preselected from a population of 700 adolescents with low omega-3 index (&lt;5%) will receive&#xD;
      daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be&#xD;
      adjusted individually to reach a target level of 8-11%. The effects on learning (academic&#xD;
      achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation,&#xD;
      goal-orientation, absenteeism), and in a subsample cognitive processes, in particular&#xD;
      perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months.&#xD;
      This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a&#xD;
      safe intervention, on a large variety of complex brain functions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>12 months</time_frame>
    <description>Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eye tracking</measure>
    <time_frame>12 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic achievement</measure>
    <time_frame>12 months</time_frame>
    <description>Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem</measure>
    <time_frame>12 months</time_frame>
    <description>Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep duration and sleep quality</measure>
    <time_frame>12 months</time_frame>
    <description>Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">266</enrollment>
  <condition>Cognitive Function</condition>
  <condition>Academic Performance</condition>
  <condition>Mental Health</condition>
  <arm_group>
    <arm_group_label>Krill oil capsules</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Capsules containing krill oil rich in omega-3 fatty acid's.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Krill oil capsules</intervention_name>
    <description>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.</description>
    <arm_group_label>Krill oil capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adolescents aged 14-15 years.&#xD;
&#xD;
          -  In lower general secondary education (MAVO/VMBO).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from hemophilia (blood clotting disorder).&#xD;
&#xD;
          -  Allergic to (shell)fish.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renate de Groot, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Open University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>De Nassau</name>
      <address>
        <city>Breda</city>
        <state>Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Graaf Engelbrecht</name>
      <address>
        <city>Breda</city>
        <state>Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newman College</name>
      <address>
        <city>Breda</city>
        <state>Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius College</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MAVO Roermond</name>
      <address>
        <city>Roermond</city>
        <state>Limburg</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr.Knippenberg College</name>
      <address>
        <city>Helmond</city>
        <state>Noord Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stabrecht College</name>
      <address>
        <city>Geldrop</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Graaf Huyn College</name>
      <address>
        <city>Geleen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scholengemeenschap Sophianum</name>
      <address>
        <city>Gulpen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Citaverde</name>
      <address>
        <city>Heerlen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grotius College</name>
      <address>
        <city>Heerlen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sintermeertencollege</name>
      <address>
        <city>Heerlen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beroepscollege Holz</name>
      <address>
        <city>Kerkrade</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bouwens van der Boijecollege</name>
      <address>
        <city>Panningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DaCapo College</name>
      <address>
        <city>Sittard</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stella Maris College</name>
      <address>
        <city>Valkenburg</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colllege Den Hulster</name>
      <address>
        <city>Venlo</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.ou.nl/food2learn</url>
    <description>Project page to inform participants and parents/legual guardians.</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Open University</investigator_affiliation>
    <investigator_full_name>Dr. Renate de Groot</investigator_full_name>
    <investigator_title>Chair Brain, Lifestyle, and Learning Program</investigator_title>
  </responsible_party>
  <keyword>Omega-3 fatty acids</keyword>
  <keyword>Cognitive function</keyword>
  <keyword>Academic performance</keyword>
  <keyword>Mental health</keyword>
  <keyword>Eye tracking</keyword>
  <keyword>Krill oil</keyword>
  <keyword>LCPUFA</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02240264
org study id: Food2Learn
secondary id: 13-T-115
nct id: NCT02240264
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Cognitive performance
time frame: 12 months
description: Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).
measure: Eye tracking
time frame: 12 months
description: 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).
measure: Academic achievement
time frame: 12 months
description: Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).
measure: Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
time frame: 12 months
description: Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem
measure: Sleep duration and sleep quality
time frame: 12 months
description: Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).
arm group label: Krill oil capsules
arm group type: Active Comparator
description: 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.
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
intervention type: Dietary Supplement
intervention name: Krill oil capsules
description: 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.
arm group label: Krill oil capsules
intervention type: Dietary Supplement
intervention name: Placebo
description: Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
arm group label: Placebo
criteria: 
gender: All
minimum age: 13 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Renate de Groot, PhD
role: Principal Investigator
affiliation: Open University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
url: http://www.ou.nl/food2learn
description: Project page to inform participants and parents/legual guardians.
responsible party type: Principal Investigator
investigator affiliation: Open University
investigator full name: Dr. Renate de Groot
investigator title: Chair Brain, Lifestyle, and Learning Program