Cardiometabolic HealthFiSK JuniorNCT02809508
The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
A study testing Oily fish and Poultry in people with Cardiometabolic Health and Cognitive Function, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Health, Cognitive Function
- What is being tested?
- Oily fish and Poultry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to 23 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C
About this study
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.
Read the 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.
- Conditions
- Cardiometabolic Health, Cognitive Function
- Being tested
- Oily fish, Poultry
- Keywords
- Omega-3, Child nutrition, Dietary recommendations, Cardiovascular risk markers, Cognitive function, Mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oily fishDietary supplement
A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch
PoultryDietary supplement
A selection of poultry, mainly chicken, provided for dinner and lunch
| Study group | Role | What they receive |
|---|---|---|
| Oily fish | Experimental | Not described Receives: Dietary Supplement: Oily fish |
| Poultry (control) | Experimental | Not described Receives: Dietary Supplement: Poultry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: At 12 weeks
Serum triacylglycerol concentration
Fasting blood level
Measured: At 12 weeks
Secondary outcomes (16)
Serum LDL cholesterol
Measured: At 12 weeks
Serum HDL cholesterol
Measured: At 12 weeks
Serum insulin
Measured: At 12 weeks
Plasma glucose
Measured: At 12 weeks
Blood glycosylated haemoglobin (HbA1c)
Measured: At 12 weeks
Heart rate
Measured: At 12 weeks
BMI z-score
Measured: At 12 weeks
Waist circumference
Measured: At 12 weeks
Fat mass index by bioimpedance
Measured: At 12 weeks
Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery
Measured: At 12 weeks
Response inhibition measured by Flanker test
Measured: At 12 weeks
Selective attention capacity measured by Stroop Test
Measured: At 12 weeks
Attention measured by the D2 Test of Attention
Measured: At 12 weeks
Saliva cortisol after cold-pressor task
Measured: At 12 weeks
Hair cortisol
Measured: At 12 weeks
Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic HealthStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, University of Waterloo
- Responsible party
- Principal investigator, Camilla Trab Damsgaard, University of Copenhagen
- Investigators
- Camilla T Damsgaard, Assoc Prof, Principal investigator, University of CopenhagenChristian Mølgaard, Prof, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809508
- Sponsor's protocol ID
- D218
- Other IDs
- H-16018225
- Acronym
- FiSK Junior
- Status last verified
- Jun 2017
- First submitted
- 6 Jun 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33515093Teisen 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.
PubMed 32529206Vuholm 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.
PubMed 31595295Damsgaard 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.
PubMed 27769289
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oily Fish and Poultry on Children's Cardiometabolic Health and Cognitive Function
- ClinicalTrials.gov ID
- NCT02809508
- Acronym / sponsor ID
- FiSK Junior / D218
- Conditions
- Cardiometabolic Health, Cognitive Function
- Keywords
- Omega-3, Child nutrition, Dietary recommendations, Cardiovascular risk markers, Cognitive function, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, University of Waterloo
- Study start
- Aug 2016 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oily fish | Experimental | Dietary Supplement: Oily fish |
| Poultry (control) | Experimental | Dietary Supplement: Poultry |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oily fishA selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch | Dietary supplement | Oily fish |
| PoultryA selection of poultry, mainly chicken, provided for dinner and lunch | Dietary supplement | Poultry (control) |
Primary outcome
Blood pressure
Time frame: At 12 weeks
Serum triacylglycerol concentration
Time frame: At 12 weeks
Fasting blood level
16 secondary outcomes
Serum LDL cholesterol
Time frame: At 12 weeks
Serum HDL cholesterol
Time frame: At 12 weeks
Serum insulin
Time frame: At 12 weeks
Plasma glucose
Time frame: At 12 weeks
Blood glycosylated haemoglobin (HbA1c)
Time frame: At 12 weeks
Heart rate
Time frame: At 12 weeks
BMI z-score
Time frame: At 12 weeks
Waist circumference
Time frame: At 12 weeks
Fat mass index by bioimpedance
Time frame: At 12 weeks
Cognitive function measured by the Cambridge Neuropsychological Test Automated Battery
Time frame: At 12 weeks
Response inhibition measured by Flanker test
Time frame: At 12 weeks
Selective attention capacity measured by Stroop Test
Time frame: At 12 weeks
Attention measured by the D2 Test of Attention
Time frame: At 12 weeks
Saliva cortisol after cold-pressor task
Time frame: At 12 weeks
Hair cortisol
Time frame: At 12 weeks
Compliance measured by content of n-3 long-chain polyunsaturated fatty acids in red blood cells
Time frame: At 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Derived from this study: PubMed 33515093Vuholm 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.
- Derived from this study: PubMed 32529206Teisen 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.
- Derived from this study: PubMed 31595295Vuholm 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.
- Derived from this study: PubMed 27769289Damsgaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla T Damsgaard, Assoc Prof principal investigator
University of Copenhagen
Christian Mølgaard, Prof study chair
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oily fish and Poultry in people with Cardiometabolic Health and Cognitive Function, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: At 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809508, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.