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The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function (FiSK Junior)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809508
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 27, 2017
Sponsor:
Collaborators:
Aalborg University Hospital
University of Waterloo
Information provided by (Responsible Party):
Camilla Trab Damsgaard, University of Copenhagen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiometabolic Health Cognitive Function Dietary Supplement: Oily fish Dietary Supplement: Poultry Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
Actual Study Start Date : August 2016
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : June 23, 2017

Arm Intervention/treatment
Experimental: Oily fish Dietary Supplement: Oily fish
A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch

Experimental: Poultry (control) Dietary Supplement: Poultry
A selection of poultry, mainly chicken, provided for dinner and lunch




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: At 12 weeks ]
  2. Serum triacylglycerol concentration [ Time Frame: At 12 weeks ]
    Fasting blood level


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809508


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, Denmark
Sponsors and Collaborators
University of Copenhagen
Aalborg University Hospital
University of Waterloo
Investigators
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Principal Investigator: Camilla T Damsgaard, Assoc Prof Department of Nutrition, Exercise and sports, University of Copenhagen
Study Chair: Christian Mølgaard, Prof Department of Nutrition, Exercise and sports, University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camilla Trab Damsgaard, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02809508    
Other Study ID Numbers: D218
H-16018225 ( Other Identifier: The Danish National Committee on Health Research Ethics )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Keywords provided by Camilla Trab Damsgaard, University of Copenhagen:
Omega-3
Child nutrition
Dietary recommendations
Cardiovascular risk markers
Cognitive function
Mental health