The Effect of Oily Fish and Poultry on Children's Cardiom... | NCT02809508

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

NCT02809508

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jun 27, 2017Actual

Enrollment

199Actual

Phase

Not Applicable

Conditions

Cardiometabolic Health
Cognitive Function

Interventions

Oily fish
Poultry

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-16018225	Other Identifier	The Danish National Committee on Health Research Ethics

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016Actual

Primary Completion Date

Jun 23, 2017Actual

Completion Date

Jun 23, 2017Actual

First Submitted Date

Jun 6, 2016

First Submission Date that Met QC Criteria

Jun 17, 2016

First Posted Date

Jun 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2017

Last Update Posted Date

Jun 27, 2017Actual

Name	Class
Aalborg University Hospital	OTHER
University of Waterloo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

199Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oily fish	Experimental		Dietary Supplement: Oily fish
Poultry (control)	Experimental		Dietary Supplement: Poultry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oily fish	Dietary Supplement	A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch	Oily fish

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Serum LDL cholesterol		At 12 weeks
Serum HDL cholesterol		At 12 weeks
Serum insulin

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camilla T Damsgaard, Assoc Prof	University of Copenhagen	Principal Investigator
Christian Mølgaard, Prof	University of Copenhagen	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nutrition, Exercise and Sports, University of Copenhagen		Frederiksberg C			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33515093	Derived	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.
32529206	Derived	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.

ID	Term
D010549	Personal Satisfaction
D001519	Behavior

ID	Term
D008460	Meat
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena