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Completed

NCT Number: NCT02331667

The Effect of Diet on Learning Abilities for Children in Kindergarden

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIFES

Bergen, 5817, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seafood

Other

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.

Non-seafood

Other

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 outcomes

  1. WPSSI-III and Nine Hole peg test.

    Time frame: 5 months

    The intervention study aims to test the effect of diet on improvement in cognitive performance measured by WPPSSI-III and Nine Hope Peg test in kindergarten children.

Secondary outcomes

  1. Mercury

    Time frame: 5 months

    Total hair mercury concentration

  2. Mental health

    Time frame: 5 months

    Strengths and difficulties questionnaire (SDQ)

  3. Sleep

    Time frame: 5 months

    Questionnaire report by parent

  4. B-vitamines

    Time frame: 5 months

    Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate

  5. Cholline pathway

    Time frame: 5 months

    Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO

  6. Tryptophan pathway

    Time frame: 5 months

    Serum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid,

  7. Amino acids

    Time frame: 5 months

    Serum: 1-MH, 3-MH, ADMa, Alanine, Arginine, Asparagine, Aspartic acid, Cystathionine, Glutamic acid, Glutamine, Histidine, Homoarginine, Isoleucine, Leucine, Lysine, Methionine, Methionine sulfoxide, Ornithine, Phenylalanine, Proline, SDMA, Threonine, Total Cysteine, Trimethyllysine, Tyrosine, Valine

  8. Inflammation

    Time frame: 5 months

    Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index

  9. Creatinine

    Time frame: 5 months

    Serum Creatinine

  10. Fatty acids

    Time frame: 5 months

    RBC: C16:3n3 (HTA), C20:5n3 (EPA), C22:6n3 (DHA), Sum n-3, C18:2n6 (LA), C30:3n6 (ETE), C20:4n6 (AA), C22:4n& (AdA), Sum n-6, Ratio n-3/n-6, C14:0, C16:0, C18:0, C22:0, C16:1, C18:1, C24:1n9

  11. Ferritin

    Time frame: 5 months

    Serum ferritin

  12. 25-hydroxyvitamin D

    Time frame: 5 months

    serum 25(OH)D3

  13. Iodine concentration

    Time frame: 5 months

    Urinary iodine concentration

Sponsors and collaborators

Lead sponsor

National Institute of Nutrition and Seafood Research, Norway

Other Gov

Collaborators

  • Ludwig-Maximilians - University of Munich
  • NORCE Norwegian Research Centre AS

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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