The Effect of Diet on Learning Abilities for Children in Kindergarden

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Diet on Learning Abilities for Children in Kindergarden

Conditions
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Cognitive Performance

Intervention / Treatment
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* Other: Seafood
* Other: Non-seafood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seafood<br>Intervention with meals consisting of seafood (herring and mackrell). | Other: Seafood<br>* 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.<br>|
| Experimental: Non-seafood<br>Intervention with meals constisting of non-seafood (meat). | Other: Non-seafood<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WPSSI-III and Nine Hole peg test. | 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. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mercury | Total hair mercury concentration | 5 months | 
| Mental health | Strengths and difficulties questionnaire (SDQ) | 5 months | 
| Sleep | Questionnaire report by parent | 5 months | 
| B-vitamines | Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate | 5 months | 
| Cholline pathway | Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO | 5 months | 
| Tryptophan pathway | Serum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid, | 5 months | 
| Amino acids | 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 | 5 months | 
| Inflammation | Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index | 5 months | 
| Creatinine | Serum Creatinine | 5 months | 
| Fatty acids | 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 | 5 months | 
| Ferritin | Serum ferritin | 5 months | 
| 25-hydroxyvitamin D | serum 25(OH)D3 | 5 months | 
| Iodine concentration | Urinary iodine concentration | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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