The Effect of Diet on Learning Abilities for Children in Kindergarden

Not Applicable

Completed

• Conditions: Cognitive Performance
• Interventions: Other: Seafood; Other: Non-seafood

• Registration Number: NCT02331667
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seafood	Seafood	Intervention with meals consisting of seafood (herring and mackrell).
Non-seafood	Non-seafood	Intervention with meals constisting of non-seafood (meat).

Primary Outcome Measures

Name	Time	Method
WPSSI-III and Nine Hole peg test.	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 Outcome Measures

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

Trial Locations

Locations (1)

NIFES; 🇳🇴 Bergen, Norway