Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-13 @ 12:50 AM
Study NCT ID:
NCT02331667
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Diet on Learning Abilities for Children in Kindergarden
Sponsor:
National Institute of Nutrition and Seafood Research, Norway
Organization:
Study Overview
Official Title:
The Effect of Diet on Learning Abilities for Children in Kindergarden
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: