Cognitive PerformanceNCT02350322
Diet and Learning Abilities in Norwegian Youths
A study testing Schoolmeal with fatty fish, Schoolmeal without fish and Supplement in people with Cognitive Performance and Health Behavior, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
Trial summary
The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance (concentration and learning abilities), mental health statua and markers of nutritional status. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Health Behavior, Nutrient Status
- What is being tested?
- Schoolmeal with fatty fish, Schoolmeal without fish and Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Jun 2015
- 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 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- girls and boys at lower secondary schools (9th grade)
Who cannot join
- allergy or intolerance to the food or food ingredients in the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance (concentration and learning abilities), mental health statua and markers of nutritional status. In addition, to disentangle the effect of fatty fish eaten as food and the effects of omega-3 fatty acids taken as a supplement.
Read the detailed description
There has been an increased attention to the role of nutrition for learning abilities among schoolchildren. As the diet provides humans with energy and several essential nutrients, a balanced supply of all nutrients promotes not only physical growth and health, but also cognitive development, helping children to learn from infancy throughout adolescence and beyond. In a three-armed non-blinded intervention trial the investigators will test whether ingestion of a schoolmeal or omega-3 capsules will improve cognitive function among pupils in 9th grade at eight lower secondary school. The pupils will be randomised into three groups, one group will be served lunch with fatty fish, one group will be served similar lunch with meat/cheese (without fish) and one group will recieve omega-3 capsules three times week over a period of 12 weeks. At the beginning and at the end of the study, pupils should conduct cognitive tests, and blood-, urine- and hair samples will be taken. The pupils should also answer a questionnaire on their diet, physical activity, sleep pattern and mental health.
- Conditions
- Cognitive Performance, Health Behavior, Nutrient Status
- Being tested
- Schoolmeal with fatty fish, Schoolmeal without fish, Supplement
- Keywords
- Diet, concentration, seafood, youths, Norway, Nutrient status in blood, Inflammatory markers
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schoolmeal with fatty fishOther
Schoolmeal with fatty fish three times a week for 12 weeks
Schoolmeal without fishOther
Schoolmeal with meat/cheese three times a week for 12 weeks
SupplementDietary supplement
Omega-3 capsules three times a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Schoolmeal with fatty fish | Experimental | Fatty fish diet Receives: Other: Schoolmeal with fatty fish |
| Schoolmeal without fish | Experimental | Meat/cheese diet (non-seafood) Receives: Other: Schoolmeal without fish |
| Supplement | Experimental | Omega-3 capsules Receives: Dietary Supplement: Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration performance and literary skills
Age stanardardized d2 test of attention. Abilities in reading and spelleing through a Norwegain based intrument developed to evaluate the childrens literacy skills in the Norwegain language.
Measured: 12 weeks
Secondary outcomes (4)
Fatty acids
Levels of fatty acids in red blood cells before and after the intervention
Measured: 12 weeks
Vitamin D status
Levels of 25-hydroxy vitamin D in serum blood before and after the intervention
Measured: 12 weeks
Mental health
Mental health status measured by the Strengths and difficulties questionnaire (SDQ)
Measured: 12 weeks
Iodine
Levels of iodine in urine samples before and after the intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition and Seafood Research, Norway
- Sponsor type
- Other government
- Collaborators
- NORCE Norwegian Research Centre AS, University of Tromso
- Responsible party
- Principal investigator, Lisbeth Dahl, National Institute of Nutrition and Seafood Research, Norway
- Investigators
- Ingvild Eide Graff, PhD, Study director, NIFES, PO Box 2029 Nordnes, N-5817 Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350322
- Sponsor's protocol ID
- FHF 900842 WP6
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Handeland K, Skotheim S, Baste V, Graff IE, Froyland L, Lie O, Kjellevold M, Markhus MW, Stormark KM, Oyen J, Dahl L. The effects of fatty fish intake on adolescents' nutritional status and associations with attention performance: results from the FINS-TEENS randomized controlled trial. Nutr J. 2018 Feb 23;17(1):30. doi: 10.1186/s12937-018-0328-z.
PubMed 29475446Handeland K, Oyen J, Skotheim S, Graff IE, Baste V, Kjellevold M, Froyland L, Lie O, Dahl L, Stormark KM. Fatty fish intake and attention performance in 14-15 year old adolescents: FINS-TEENS - a randomized controlled trial. Nutr J. 2017 Oct 2;16(1):64. doi: 10.1186/s12937-017-0287-9.
PubMed 28969711
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Learning Abilities in Norwegian Youths
- ClinicalTrials.gov ID
- NCT02350322
- Acronym / sponsor ID
- FHF 900842 WP6
- Conditions
- Cognitive Performance, Health Behavior, Nutrient Status
- Keywords
- Diet, concentration, seafood, youths, Norway, Nutrient status in blood, Inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- National Institute of Nutrition and Seafood Research, NorwayOther government
- Collaborators
- NORCE Norwegian Research Centre AS, University of Tromso
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Jan 2015 (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 aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance (concentration and learning abilities), mental health statua and markers of nutritional status. In addition, to disentangle the effect of fatty fish eaten as food and the effects of omega-3 fatty acids taken as a supplement.
Detailed description
There has been an increased attention to the role of nutrition for learning abilities among schoolchildren. As the diet provides humans with energy and several essential nutrients, a balanced supply of all nutrients promotes not only physical growth and health, but also cognitive development, helping children to learn from infancy throughout adolescence and beyond. In a three-armed non-blinded intervention trial the investigators will test whether ingestion of a schoolmeal or omega-3 capsules will improve cognitive function among pupils in 9th grade at eight lower secondary school. The pupils will be randomised into three groups, one group will be served lunch with fatty fish, one group will be served similar lunch with meat/cheese (without fish) and one group will recieve omega-3 capsules three times week over a period of 12 weeks. At the beginning and at the end of the study, pupils should conduct cognitive tests, and blood-, urine- and hair samples will be taken. The pupils should also answer a questionnaire on their diet, physical activity, sleep pattern and mental health.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schoolmeal with fatty fish | Experimental | Other: Schoolmeal with fatty fishFatty fish diet |
| Schoolmeal without fish | Experimental | Other: Schoolmeal without fishMeat/cheese diet (non-seafood) |
| Supplement | Experimental | Dietary Supplement: SupplementOmega-3 capsules |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- girls and boys at lower secondary schools (9th grade)
Key exclusion criteria (1 listed)
- allergy or intolerance to the food or food ingredients in the study
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 |
|---|---|---|
| Schoolmeal with fatty fishSchoolmeal with fatty fish three times a week for 12 weeks | Other | Schoolmeal with fatty fish |
| Schoolmeal without fishSchoolmeal with meat/cheese three times a week for 12 weeks | Other | Schoolmeal without fish |
| SupplementOmega-3 capsules three times a week for 12 weeks | Dietary supplement | Supplement |
Primary outcome
Concentration performance and literary skills
Time frame: 12 weeks
Age stanardardized d2 test of attention. Abilities in reading and spelleing through a Norwegain based intrument developed to evaluate the childrens literacy skills in the Norwegain language.
4 secondary outcomes
Fatty acids
Time frame: 12 weeks
Vitamin D status
Time frame: 12 weeks
Mental health
Time frame: 12 weeks
Iodine
Time frame: 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 12 Jan 2016.
- Derived from this study: PubMed 29475446Handeland K, Skotheim S, Baste V, Graff IE, Froyland L, Lie O, Kjellevold M, Markhus MW, Stormark KM, Oyen J, Dahl L. The effects of fatty fish intake on adolescents' nutritional status and associations with attention performance: results from the FINS-TEENS randomized controlled trial. Nutr J. 2018 Feb 23;17(1):30. doi: 10.1186/s12937-018-0328-z.
- Derived from this study: PubMed 28969711Handeland K, Oyen J, Skotheim S, Graff IE, Baste V, Kjellevold M, Froyland L, Lie O, Dahl L, Stormark KM. Fatty fish intake and attention performance in 14-15 year old adolescents: FINS-TEENS - a randomized controlled trial. Nutr J. 2017 Oct 2;16(1):64. doi: 10.1186/s12937-017-0287-9.
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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.
Ingvild Eide Graff, PhD study director
NIFES, PO Box 2029 Nordnes, N-5817 Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schoolmeal with fatty fish, Schoolmeal without fish and Supplement in people with Cognitive Performance and Health Behavior, run by National Institute of Nutrition and Seafood Research, Norway at 1 site in Norway.
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 1 inclusion and 1 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 12 Jan 2016. 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 Norway. 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?
Concentration performance and literary skills (time frame: 12 weeks). 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 NCT02350322, which also lists 2 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 12 Jan 2016.