The Effect of Diet on Learning Abilities for Children in Kindergarden

November 23, 2020 updated by: Jannike Øyen, National Institute of Nutrition and Seafood Research, Norway
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5817
        • NIFES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Seafood
Intervention with meals consisting of seafood (herring and mackrell).
Other: 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.
EXPERIMENTAL: Non-seafood
Intervention with meals constisting of non-seafood (meat).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mercury
Time Frame: 5 months
Total hair mercury concentration
5 months
Mental health
Time Frame: 5 months
Strengths and difficulties questionnaire (SDQ)
5 months
Sleep
Time Frame: 5 months
Questionnaire report by parent
5 months
B-vitamines
Time Frame: 5 months
Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate
5 months
Cholline pathway
Time Frame: 5 months
Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO
5 months
Tryptophan pathway
Time Frame: 5 months
Serum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid,
5 months
Amino acids
Time Frame: 5 months
Serum: 1-MH, 3-MH, ADMa, Alanine, Arginine, Asparagine, Aspartic acid, Cystathionine, Glutamic acid, Glutamine, Histidine, Homoarginine, Isoleucine, Leucine, Lysine, Methionine, Methionine sulfoxide, Ornithine, Phenylalanine, Proline, SDMA, Threonine, Total Cysteine, Trimethyllysine, Tyrosine, Valine
5 months
Inflammation
Time Frame: 5 months
Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index
5 months
Creatinine
Time Frame: 5 months
Serum Creatinine
5 months
Fatty acids
Time Frame: 5 months
RBC: C16:3n3 (HTA), C20:5n3 (EPA), C22:6n3 (DHA), Sum n-3, C18:2n6 (LA), C30:3n6 (ETE), C20:4n6 (AA), C22:4n& (AdA), Sum n-6, Ratio n-3/n-6, C14:0, C16:0, C18:0, C22:0, C16:1, C18:1, C24:1n9
5 months
Ferritin
Time Frame: 5 months
Serum ferritin
5 months
25-hydroxyvitamin D
Time Frame: 5 months
serum 25(OH)D3
5 months
Iodine concentration
Time Frame: 5 months
Urinary iodine concentration
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Nutrition and Seafood Research, Norway

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ludwig-Maximilians - University of Munich
NORCE Norwegian Research Centre AS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ingvild Eide Graff, PhD, NIFES, Postboks 2029 Nordnes, 5817 Bergen, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/1396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results will be published in international journals.

IPD Sharing Time Frame

From study start until 2023

IPD Sharing Access Criteria

Upon request to the project manager.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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