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The Effect of Diet on Learning Abilities for Children in Kindergarden

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ClinicalTrials.gov Identifier: NCT02331667
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : December 19, 2016
Sponsor:
Collaborators:
NORCE Norwegian Research Centre AS
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Jannike Øyen, National Institute of Nutrition and Seafood Research, Norway

Brief Summary:
The main aim of this intervention study is to test the effect of diet on improvement in cognitive performanc in kindergarden children aged 4-6 years. Children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group.

Condition or disease Intervention/treatment Phase
Cognitive Performance Other: Seafood Other: Non-seafood Not Applicable

Detailed Description:
Positive effects of n-3 long chain polyunsaturated fatty acids (PUFAs), as provided by fatty fish intake, on cognitive functions are widely accepted, but so far there is no clear evidence from randomized intervention studies in children and young adults, although fish intake has been positively associated with cognitive functions in observational studies. The main aim of this study is to test the effect of diet on improvement in cognitive performance in kindergarden children aged 4-6 years. In the intervention study, children will be randomly allocated into two groups, one consuming prepared meals with herring or mackerel for four months, and one group consuming meals containing meat as a control group. The children (n=200) will consume the prepared meals three times a week. Cognitive performance of the children will be tested at study start and end using the the Wechsler Preschool and Primary Scale of Intelligence (WPPSI_III) and nine hole peg test. Children will be screened for mental health problems in the Strengths and Difficulties Questionnaire (SDQ), which is a global measure of children's mental health. Compliance will be monitored by documentation of study fish intake and measuring fatty acid status. For a more detailed investigation of effects of increased herring and mackerel intake, before and after intervention blood and urine will be collected for lipidomic analysis (metabolites), vitamin D and iodine determination and genotyping (fatty acid metabolism and inflammation).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effect of Diet on Learning Abilities for Children in Kindergarden
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Seafood
Intervention with meals consisting of seafood (herring and mackrell).
Other: Seafood
The aim is to investigate the effect of meals consisting of mackrel and herring on learning abilities by using a two-armed individually randomized non-blinded intervention trial.

Experimental: Non-seafood
Intervention with meals constisting of non-seafood (meat).
Other: Non-seafood
The aim is to investigate the effect of meals consisting of meat on learning abilities by using a two-armed individually randomized non-blinded intervention trial.




Primary Outcome Measures :
  1. The intervention study aims to test the effect of diet on improvement in cognitive performance measured by WPSS_III and Nine Hole peg test in kindergarden children. [ Time Frame: 5 months ]


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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being 4-6 years old.
  • Sufficient command of the Norwegian language of child to participate in cognitive testing and of child and parents to comply with study requirements according to investigators estimation.

Exclusion Criteria:

  • Known food allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331667


Locations
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Norway
NIFES
Bergen, Norway, 5817
Sponsors and Collaborators
National Institute of Nutrition and Seafood Research, Norway
NORCE Norwegian Research Centre AS
Ludwig-Maximilians - University of Munich
Investigators
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Study Director: Ingvild Eide Graff, PhD NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jannike Øyen, PhD, Scientist, National Institute of Nutrition and Seafood Research, Norway
ClinicalTrials.gov Identifier: NCT02331667     History of Changes
Other Study ID Numbers: 2014/1396
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results will be published in international journals.
Keywords provided by Jannike Øyen, National Institute of Nutrition and Seafood Research, Norway:
Diet
Vitamin-D
Meat
Fatty fish
Iodine
fatty acid
Intervention study
Wechsler Preschool and Primary Scale of Intelligence
Strengths and Difficulties Questionnaire
Nine hole peg test