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

NCT02809508 | Completed DMC

• 2 other identifiers: D218H-16018225
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Health; Cognitive Function

Keywords

Omega-3; Child nutrition; Dietary recommendations; Cardiovascular risk markers; Cognitive function; Mental health

Outcome Measures

Primary Outcomes (2)

• Blood pressure

  At 12 weeks

• Serum triacylglycerol concentration

  Fasting blood level

  At 12 weeks

Secondary Outcomes (16)

• Serum LDL cholesterol

  At 12 weeks

• Serum HDL cholesterol

  At 12 weeks

• Serum insulin

  At 12 weeks

• Plasma glucose

  At 12 weeks

• Blood glycosylated haemoglobin (HbA1c)

  At 12 weeks

Other Outcomes (6)

• Behaviour measured by the Strengths and Difficulties Questionnaire

  At 12 weeks

• Behaviour measured by the Behavior Rating Inventory of Executive Function Questionnaire

  At 12 weeks

• Serum insulin-like growth factor-1

  At 12 weeks

Study Arms (2)

Oily fish

EXPERIMENTAL

Dietary Supplement: Oily fish

Poultry (control)

EXPERIMENTAL

Dietary Supplement: Poultry

Interventions

Oily fish DIETARY_SUPPLEMENT

A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch

Oily fish

Poultry DIETARY_SUPPLEMENT

A selection of poultry, mainly chicken, provided for dinner and lunch

Poultry (control)

Eligibility Criteria

• Age: 8 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Aalborg University Hospital: collaborator
• University of Waterloo: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, Denmark

Location

Related Publications (4)

• 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.

  PMID: 33515093 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.

  PMID: 32529206 DERIVED

• 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.

  PMID: 31595295 DERIVED

• 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.

  PMID: 27769289 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Poultry

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Meat; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Camilla T Damsgaard, Assoc Prof

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Christian Mølgaard, Prof

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 22, 2016
• Study Start: August 1, 2016
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

DK (1)