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Completed

NCT Number: NCT02809508

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

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.

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Key information

Age range

8 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oily fish

Dietary Supplement

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

Poultry

Dietary Supplement

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

Primary outcomes

  1. Blood pressure

    Time frame: At 12 weeks

  2. Serum triacylglycerol concentration

    Time frame: At 12 weeks

    Fasting blood level

Secondary outcomes

  1. Serum LDL cholesterol

    Time frame: At 12 weeks

  2. Serum HDL cholesterol

    Time frame: At 12 weeks

  3. Serum insulin

    Time frame: At 12 weeks

  4. Plasma glucose

    Time frame: At 12 weeks

  5. Blood glycosylated haemoglobin (HbA1c)

    Time frame: At 12 weeks

  6. Heart rate

    Time frame: At 12 weeks

  7. BMI z-score

    Time frame: At 12 weeks

  8. Waist circumference

    Time frame: At 12 weeks

  9. Fat mass index by bioimpedance

    Time frame: At 12 weeks

  10. Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery

    Time frame: At 12 weeks

  11. Response inhibition measured by Flanker test

    Time frame: At 12 weeks

  12. Selective attention capacity measured by Stroop Test

    Time frame: At 12 weeks

  13. Attention measured by the D2 Test of Attention

    Time frame: At 12 weeks

  14. Saliva cortisol after cold-pressor task

    Time frame: At 12 weeks

  15. Hair cortisol

    Time frame: At 12 weeks

  16. Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells

    Time frame: At 12 weeks

Other outcomes

  1. Behaviour measured by the Strengths and Difficulties Questionnaire

    Time frame: At 12 weeks

    Administered to parent

  2. Behaviour measured by the Behavior Rating Inventory of Executive Function Questionnaire

    Time frame: At 12 weeks

    Administered to parent

  3. Serum insulin-like growth factor-1

    Time frame: At 12 weeks

  4. Serum C-reactive protein

    Time frame: At 12 weeks

  5. Serum 25-hydroxy-vitamin D

    Time frame: At 12 weeks

  6. Physical activity

    Time frame: At 12 weeks

    Measured by accelerometry

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Aalborg University Hospital
  • University of Waterloo

Registry information

Acronym: FiSK Junior

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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