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The Effect of Diet on Learning Abilities for Children in Kindergarden

NCT ID: NCT02331667

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-06-30

Brief Summary

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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

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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).

Conditions

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Cognitive Performance

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Seafood

Intervention with meals consisting of seafood (herring and mackrell).

Group Type EXPERIMENTAL

Seafood

Intervention Type OTHER

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

Intervention with meals constisting of non-seafood (meat).

Group Type EXPERIMENTAL

Non-seafood

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NORCE Norwegian Research Centre AS

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

National Institute of Nutrition and Seafood Research, Norway

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jannike Øyen

PhD, Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingvild Eide Graff, PhD

Role: STUDY_DIRECTOR

NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway

Locations

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NIFES

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 33978160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32338756 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29530020 (View on PubMed)

Other Identifiers

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2014/1396

Identifier Type: -

Identifier Source: org_study_id