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

Cognitive Function Clinical Trial

— FiSK Junior  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809508
• Other study ID #: D218
• Secondary ID: H-16018225
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 26, 2017
• Start date: August 2016
• Est. completion date: June 23, 2017

Study information

• Verified date: June 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Health
• Cognitive Function

Intervention

Dietary Supplement:
• Oily fish
A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch
• Poultry
A selection of poultry, mainly chicken, provided for dinner and lunch

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg C

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Aalborg Universitetshospital, University of Waterloo

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behaviour measured by the Strengths and Difficulties Questionnaire	Administered to parent	At 12 weeks
Other	Behaviour measured by the Behavior Rating Inventory of Executive Function Questionnaire	Administered to parent	At 12 weeks
Other	Serum insulin-like growth factor-1		At 12 weeks
Other	Serum C-reactive protein		At 12 weeks
Other	Serum 25-hydroxy-vitamin D		At 12 weeks
Other	Physical activity	Measured by accelerometry	At 12 weeks
Primary	Blood pressure		At 12 weeks
Primary	Serum triacylglycerol concentration	Fasting blood level	At 12 weeks
Secondary	Serum LDL cholesterol		At 12 weeks
Secondary	Serum HDL cholesterol		At 12 weeks
Secondary	Serum insulin		At 12 weeks
Secondary	Plasma glucose		At 12 weeks
Secondary	Blood glycosylated haemoglobin (HbA1c)		At 12 weeks
Secondary	Heart rate		At 12 weeks
Secondary	BMI z-score		At 12 weeks
Secondary	Waist circumference		At 12 weeks
Secondary	Fat mass index by bioimpedance		At 12 weeks
Secondary	Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery		At 12 weeks
Secondary	Response inhibition measured by Flanker test		At 12 weeks
Secondary	Selective attention capacity measured by Stroop Test		At 12 weeks
Secondary	Attention measured by the D2 Test of Attention		At 12 weeks
Secondary	Saliva cortisol after cold-pressor task		At 12 weeks
Secondary	Hair cortisol		At 12 weeks
Secondary	Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells		At 12 weeks