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The Effect of Diet on Learning Abilities for Children in Kindergarden

The Effect of Diet on Learning Abilities for Children in Kindergarden

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02331667
Enrollment
233
Registered
2015-01-06
Start date
2014-12-31
Completion date
2015-06-30
Last updated
2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Performance

Keywords

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

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.

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).

Interventions

OTHERSeafood

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.

OTHERNon-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.

Sponsors

NORCE Norwegian Research Centre AS
CollaboratorOTHER
Ludwig-Maximilians - University of Munich
CollaboratorOTHER
National Institute of Nutrition and Seafood Research, Norway
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
WPSSI-III and Nine Hole peg test.5 monthsThe 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

MeasureTime frameDescription
Mental health5 monthsStrengths and difficulties questionnaire (SDQ)
Sleep5 monthsQuestionnaire report by parent
B-vitamines5 monthsSerum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate
Cholline pathway5 monthsSerum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO
Tryptophan pathway5 monthsSerum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid,
Amino acids5 monthsSerum: 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
Mercury5 monthsTotal hair mercury concentration
Creatinine5 monthsSerum Creatinine
Fatty acids5 monthsRBC: 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
Ferritin5 monthsSerum ferritin
25-hydroxyvitamin D5 monthsserum 25(OH)D3
Iodine concentration5 monthsUrinary iodine concentration
Inflammation5 monthsSerum: Kynureine/Tryptophan-ratio, Neopterin, PAr index

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026