NCT02331667

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

December 17, 2014

Last Update Submit

November 23, 2020

Conditions

Cognitive Performance

Keywords

DietVitamin-DMeatFatty fishIodinefatty acidIntervention studyWechsler Preschool and Primary Scale of IntelligenceStrengths and Difficulties QuestionnaireNine hole peg test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Mercury

    5 months

  • Mental health

    5 months

  • Sleep

    5 months

  • B-vitamines

    5 months

  • Cholline pathway

    5 months

  • +8 more secondary outcomes

Study Arms (2)

Seafood

EXPERIMENTAL

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

Other: Seafood

Non-seafood

EXPERIMENTAL

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

Other: Non-seafood

Interventions

SeafoodOTHER

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.

Seafood
Non-seafoodOTHER

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.

Non-seafood

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Known food allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIFES

Bergen, 5817, Norway

Location

Related Publications (3)

  • 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.

    PMID: 33978160DERIVED

  • 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.

    PMID: 32338756DERIVED

  • 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.

    PMID: 29530020DERIVED

MeSH Terms

Interventions

Seafood

Intervention Hierarchy (Ancestors)

MeatFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ingvild Eide Graff, PhD

    NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Scientist

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 6, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

The results will be published in international journals.

Shared Documents
STUDY PROTOCOL
Time Frame
From study start until 2023
Access Criteria
Upon request to the project manager.

Locations

NO(1)