The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function

NCT ID: NCT02809508

Last Updated: 2017-06-27

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

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-06-23

Brief Summary

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The purpose of FiSK Junior is to investigate whether intake of oily fish compared to poultry affects cardiovascular risk markers, cognitive function, and behaviour in healthy children.

Detailed Description

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The FiSK Junior study compares the effects of consuming oily fish versus poultry (control) in healthy 8-9 year-old Danish children. The children will be randomized to consume approximately 300 g/week of either oily fish or poultry for 12 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.

The main objective of the study is to investigate the effect on cardiovascular risk markers, primarily blood pressure and plasma triacylglycerol. Moreover, the effects on cognitive function, behaviour, emotions and physiological stress response will be assessed. In addition, change in n-3 long chain polyunsaturated fatty acid status (compliance), anthropometry, body composition, vitamin D status, inflammatory markers, growth markers, physical activity and diet will be measured. Outcomes will be analysed with focus on potential gender- and genotype-specific effects.

Conditions

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Cardiometabolic Health Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Oily fish

Group Type EXPERIMENTAL

Oily fish

Intervention Type DIETARY_SUPPLEMENT

A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch

Poultry (control)

Group Type EXPERIMENTAL

Poultry

Intervention Type DIETARY_SUPPLEMENT

A selection of poultry, mainly chicken, provided for dinner and lunch

Interventions

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Oily fish

A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch

Intervention Type DIETARY_SUPPLEMENT

Poultry

A selection of poultry, mainly chicken, provided for dinner and lunch

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Children must:

* Be 8 - 9 years of age at the start of the intervention
* Be healthy
* Like oily fish and chicken
* Be willing to be randomized to eat fish or chicken
* Not consume oily fish more than once per week 3 months prior to intervention start
* Not consume fish oil 3 months prior to intervention start
* Speak Danish in order to understand the study procedures

Moreover:

* Parents must read and speak Danish, in order to be properly informed about the study procedures
* The child must live in a household with ≤5 persons

Exclusion Criteria

* Serious chronic illnesses and diseases that may interfere with study outcomes
* Diagnosed Attention Deficit Hyperactivity Disorder (ADHD) or other psychiatric illness
* Intake of medication that may affect study outcomes
* Concomitant participation in other studies involving dietary supplements or blood sampling
* Living in a household with another participating child
Minimum Eligible Age

8 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

University of Waterloo

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Camilla Trab Damsgaard

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camilla T Damsgaard, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Exercise and sports, University of Copenhagen

Christian Mølgaard, Prof

Role: STUDY_CHAIR

Department of Nutrition, Exercise and sports, University of Copenhagen

Locations

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Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, , Denmark

Site Status

Countries

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Denmark

References

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Vuholm S, Teisen MN, Molgaard C, Lauritzen L, Damsgaard CT. Sleep and physical activity in healthy 8-9-year-old children are affected by oily fish consumption in the FiSK Junior randomized trial. Eur J Nutr. 2021 Sep;60(6):3095-3106. doi: 10.1007/s00394-021-02490-7. Epub 2021 Jan 30.

Reference Type DERIVED
PMID: 33515093 (View on PubMed)

Teisen MN, Vuholm S, Niclasen J, Aristizabal-Henao JJ, Stark KD, Geertsen SS, Damsgaard CT, Lauritzen L. Effects of oily fish intake on cognitive and socioemotional function in healthy 8-9-year-old children: the FiSK Junior randomized trial. Am J Clin Nutr. 2020 Jul 1;112(1):74-83. doi: 10.1093/ajcn/nqaa050.

Reference Type DERIVED
PMID: 32529206 (View on PubMed)

Vuholm S, Rantanen JM, Teisen MN, Stark KD, Molgaard C, Christensen JH, Lauritzen L, Damsgaard CT. Effects of oily fish intake on cardiometabolic markers in healthy 8- to 9-y-old children: the FiSK Junior randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1296-1305. doi: 10.1093/ajcn/nqz233.

Reference Type DERIVED
PMID: 31595295 (View on PubMed)

Damsgaard CT, Lauritzen L, Hauger H, Vuholm S, Teisen MN, Ritz C, Hansen M, Niclasen J, Molgaard C. Effects of oily fish intake on cardiovascular risk markers, cognitive function, and behavior in school-aged children: study protocol for a randomized controlled trial. Trials. 2016 Oct 21;17(1):510. doi: 10.1186/s13063-016-1647-z.

Reference Type DERIVED
PMID: 27769289 (View on PubMed)

Other Identifiers

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H-16018225

Identifier Type: OTHER

Identifier Source: secondary_id

D218

Identifier Type: -

Identifier Source: org_study_id

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