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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Cardiometabolic Health
• Intervention / Treatment: Dietary supplement: Oily fish; Dietary supplement: Poultry

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.

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg C, Denmark
    • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		At 12 weeks
Serum triacylglycerol concentration	Fasting blood level	At 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum LDL cholesterol	At 12 weeks
Serum HDL cholesterol	At 12 weeks
Serum insulin	At 12 weeks
Plasma glucose	At 12 weeks
Blood glycosylated haemoglobin (HbA1c)	At 12 weeks
Heart rate	At 12 weeks
BMI z-score	At 12 weeks
Waist circumference	At 12 weeks
Fat mass index by bioimpedance	At 12 weeks
Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery	At 12 weeks
Response inhibition measured by Flanker test	At 12 weeks
Selective attention capacity measured by Stroop Test	At 12 weeks
Attention measured by the D2 Test of Attention	At 12 weeks
Saliva cortisol after cold-pressor task	At 12 weeks
Hair cortisol	At 12 weeks
Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells	At 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behaviour measured by the Strengths and Difficulties Questionnaire	Administered to parent	At 12 weeks
Behaviour measured by the Behavior Rating Inventory of Executive Function Questionnaire	Administered to parent	At 12 weeks
Serum insulin-like growth factor-1		At 12 weeks
Serum C-reactive protein		At 12 weeks
Serum 25-hydroxy-vitamin D		At 12 weeks
Physical activity	Measured by accelerometry	At 12 weeks

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Aalborg University Hospital; University of Waterloo
• Investigators: 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 and helpful links

General Publications

• Vuholm S, Teisen MN, Mølgaard 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 23, 2017
• Study Completion (Actual): June 23, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Cognitive function; Mental health; Omega-3; Child nutrition; Dietary recommendations; Cardiovascular risk markers
• Other Study ID Numbers: D218; H-16018225 (Other Identifier: The Danish National Committee on Health Research Ethics)