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

Not Applicable

Completed

• Conditions: Cardiometabolic Health; Cognitive Function
• Interventions: Dietary Supplement: Oily fish; Dietary Supplement: Poultry

• Registration Number: NCT02809508
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-22
• Study Start: 2016-08
• Status Verified: 2017-06
• Primary Completion: 2017-06-23
• Study Completion: 2017-06-23
• Last Update Submitted: 2017-06-26
• Last Update Posted: 2017-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oily fish	Oily fish	-
Poultry (control)	Poultry	-

Primary Outcome Measures

Name	Time	Method
Blood pressure	At 12 weeks
Serum triacylglycerol concentration	At 12 weeks	Fasting blood level

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen; 🇩🇰 Frederiksberg C, Denmark