Clinical trial NCT02331667: The Effect of Diet on Learning Abilities for Children in Kindergarden
Official title: The Effect of Diet on Learning Abilities for Children in Kindergarden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Keywords: 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
Lead sponsor: National Institute of Nutrition and Seafood Research, Norway
Sponsor class: OTHER_GOV
Collaborators: name: NORCE Norwegian Research Centre AS
name: Ludwig-Maximilians - University of Munich
First posted: 2015-01-06
Enrollment: 233
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: WPSSI-III and Nine Hole peg test.
timeFrame: 5 months
Secondary outcomes:
measure: Mercury
timeFrame: 5 months
measure: Mental health
timeFrame: 5 months
measure: Sleep
timeFrame: 5 months
measure: B-vitamines
timeFrame: 5 months
measure: Cholline pathway
timeFrame: 5 months
measure: Tryptophan pathway
timeFrame: 5 months
measure: Amino acids
timeFrame: 5 months
measure: Inflammation
timeFrame: 5 months
measure: Creatinine
timeFrame: 5 months
measure: Fatty acids
timeFrame: 5 months
measure: Ferritin
timeFrame: 5 months
measure: 25-hydroxyvitamin D
timeFrame: 5 months
measure: Iodine concentration
timeFrame: 5 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: NIFES
Study officials:
affiliation: NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway
name: Ingvild Eide Graff, PhD
role: STUDY_DIRECTOR
References:
citation: Solvik BS, Oyen J, Kvestad I, Markhus MW, Ueland PM, McCann A, Strand TA. Biomarkers and Fatty Fish Intake: A Randomized Controlled Trial in Norwegian Preschool Children. J Nutr. 2021 Aug 7;151(8):2134-2141. doi: 10.1093/jn/nxab112.
citation: Solvik BS, Strand TA, Kvestad I, Markhus MW, Ueland PM, McCann A, Oyen J. Dietary Intake and Biomarkers of Folate and Cobalamin Status in Norwegian Preschool Children: The FINS-KIDS Study. J Nutr. 2020 Jul 1;150(7):1852-1858. doi: 10.1093/jn/nxaa111.
citation: Oyen J, Kvestad I, Midtbo LK, Graff IE, Hysing M, Stormark KM, Markhus MW, Baste V, Froyland L, Koletzko B, Demmelmair H, Dahl L, Lie O, Kjellevold M. Fatty fish intake and cognitive function: FINS-KIDS, a randomized controlled trial in preschool children. BMC Med. 2018 Mar 12;16(1):41. doi: 10.1186/s12916-018-1020-z.