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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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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