Clinical trial NCT02809508: The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
Official title: The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Health
Cognitive Function
Keywords: Omega-3
Child nutrition
Dietary recommendations
Cardiovascular risk markers
Cognitive function
Mental health
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: University of Waterloo
First posted: 2016-06-22
Enrollment: 199
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Blood pressure
timeFrame: At 12 weeks
measure: Serum triacylglycerol concentration
timeFrame: At 12 weeks
Secondary outcomes:
measure: Serum LDL cholesterol
timeFrame: At 12 weeks
measure: Serum HDL cholesterol
timeFrame: At 12 weeks
measure: Serum insulin
timeFrame: At 12 weeks
measure: Plasma glucose
timeFrame: At 12 weeks
measure: Blood glycosylated haemoglobin (HbA1c)
timeFrame: At 12 weeks
measure: Heart rate
timeFrame: At 12 weeks
measure: BMI z-score
timeFrame: At 12 weeks
measure: Waist circumference
timeFrame: At 12 weeks
measure: Fat mass index by bioimpedance
timeFrame: At 12 weeks
measure: Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery
timeFrame: At 12 weeks
measure: Response inhibition measured by Flanker test
timeFrame: At 12 weeks
measure: Selective attention capacity measured by Stroop Test
timeFrame: At 12 weeks
measure: Attention measured by the D2 Test of Attention
timeFrame: At 12 weeks
measure: Saliva cortisol after cold-pressor task
timeFrame: At 12 weeks
measure: Hair cortisol
timeFrame: At 12 weeks
measure: Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells
timeFrame: At 12 weeks
Other outcomes:
measure: Behaviour measured by the Strengths and Difficulties Questionnaire
timeFrame: At 12 weeks
measure: Behaviour measured by the Behavior Rating Inventory of Executive Function Questionnaire
timeFrame: At 12 weeks
measure: Serum insulin-like growth factor-1
timeFrame: At 12 weeks
measure: Serum C-reactive protein
timeFrame: At 12 weeks
measure: Serum 25-hydroxy-vitamin D
timeFrame: At 12 weeks
measure: Physical activity
timeFrame: At 12 weeks
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Camilla T Damsgaard, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Exercise and sports, University of Copenhagen
name: Christian Mølgaard, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.