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Clinical Trials/NCT02331667
NCT02331667
Completed
Not Applicable

The Effect of Diet on Learning Abilities for Children in Kindergarden

National Institute of Nutrition and Seafood Research, Norway1 site in 1 country233 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Performance
Sponsor
National Institute of Nutrition and Seafood Research, Norway
Enrollment
233
Locations
1
Primary Endpoint
WPSSI-III and Nine Hole peg test.
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
June 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Institute of Nutrition and Seafood Research, Norway
Responsible Party
Principal Investigator
Principal Investigator

Jannike Øyen

PhD, Scientist

National Institute of Nutrition and Seafood Research, Norway

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Mercury(5 months)
  • Mental health(5 months)
  • Sleep(5 months)
  • B-vitamines(5 months)
  • Cholline pathway(5 months)
  • Tryptophan pathway(5 months)
  • Amino acids(5 months)
  • Inflammation(5 months)
  • Creatinine(5 months)
  • Fatty acids(5 months)
  • Ferritin(5 months)
  • 25-hydroxyvitamin D(5 months)
  • Iodine concentration(5 months)

Study Sites (1)

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