The Effect of Diet on Learning Abilities for Children in Kindergarden

Cognitive Performance Clinical Trial

Official title:

The Effect of Diet on Learning Abilities for Children in Kindergarden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331667
• Other study ID #: 2014/1396
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2020
• Source: National Institute of Nutrition and Seafood Research, Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	NIFES	Bergen

Sponsors (3)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mercury	Total hair mercury concentration	5 months
Secondary	Mental health	Strengths and difficulties questionnaire (SDQ)	5 months
Secondary	Sleep	Questionnaire report by parent	5 months
Secondary	B-vitamines	Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate	5 months
Secondary	Cholline pathway	Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO	5 months
Secondary	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
Secondary	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
Secondary	Inflammation	Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index	5 months
Secondary	Creatinine	Serum Creatinine	5 months
Secondary	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
Secondary	Ferritin	Serum ferritin	5 months
Secondary	25-hydroxyvitamin D	serum 25(OH)D3	5 months
Secondary	Iodine concentration	Urinary iodine concentration	5 months