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Cognitive PerformanceNCT02331667

The Effect of Diet on Learning Abilities for Children in Kindergarden

A study testing Seafood and Non-seafood in people with Cognitive Performance, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Performance
What is being tested?
Seafood and Non-seafood
Could I receive a placebo?
No, everyone receives an active treatment
How many people
233 participants
Where
1 siteNorway
Study dates
Dec 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Known food allergies

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • NIFES

    Bergen, 5817

Other trials in Norway

About this study

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.

Read the 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).

Being tested
Seafood, Non-seafood
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT02331667
Study groupRoleWhat they receive
SeafoodExperimentalIntervention with meals consisting of seafood (herring and mackrell).
Receives: Other: Seafood
Non-seafoodExperimentalIntervention with meals constisting of non-seafood (meat).
Receives: Other: Non-seafood

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 months

Secondary outcomes (13)

  1. Mercury

    Total hair mercury concentration

    Measured: 5 months

  2. Mental health

    Strengths and difficulties questionnaire (SDQ)

    Measured: 5 months

  3. Sleep

    Questionnaire report by parent

    Measured: 5 months

  4. B-vitamines

    Serum: Cobalamin, Flavin Mononucleotide, Folate, HCC-index, HK:XA, MMA, N1-methylnicotinamide, PA, PL, PLP, Riboflavin, tHcy, Thiamin, Thiamin monophosphate

    Measured: 5 months

  5. Cholline pathway

    Serum: Betaine, Choline, Dimethylglycine, Glycine, Serine, TMAO

    Measured: 5 months

  6. Tryptophan pathway

    Serum: 3-Hydroxyanthranilic acids, 3-Hydroxykynurenine, Anthranilic acid, Kynurenic acid, Kynurenine, Tryptophan, Xanthurenic acid, Nicotinamide, Picolinic acid, Quinolic acid c acid,

    Measured: 5 months

  7. Amino acids

    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

    Measured: 5 months

  8. Inflammation

    Serum: Kynureine/Tryptophan-ratio, Neopterin, PAr index

    Measured: 5 months

  9. Creatinine

    Serum Creatinine

    Measured: 5 months

  10. Fatty acids

    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

    Measured: 5 months

  11. Ferritin

    Serum ferritin

    Measured: 5 months

  12. 25-hydroxyvitamin D

    serum 25(OH)D3

    Measured: 5 months

  13. Iodine concentration

    Urinary iodine concentration

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02331667
Sponsor's protocol ID
2014/1396
Status last verified
Nov 2020
First submitted
17 Dec 2014
Last updated
27 Nov 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The results will be published in international journals.

Publications

  • 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.

    PubMed 33978160

  • 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.

    PubMed 32338756

  • 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.

    PubMed 29530020

Questions about this trial

What is this clinical trial studying?

A study testing Seafood and Non-seafood in people with Cognitive Performance, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WPSSI-III and Nine Hole peg test. (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02331667, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.

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