- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02350322
Diet and Learning Abilities in Norwegian Youths
January 11, 2016 updated by: Lisbeth Dahl, National Institute of Nutrition and Seafood Research, Norway
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
478
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bergen, Norway, 5004
- Lisbeth Dahl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- girls and boys at lower secondary schools (9th grade)
Exclusion Criteria:
- allergy or intolerance to the food or food ingredients in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Schoolmeal with fatty fish
Fatty fish diet
|
Schoolmeal with fatty fish three times a week for 12 weeks
|
Experimental: Schoolmeal without fish
Meat/cheese diet (non-seafood)
|
Schoolmeal with meat/cheese three times a week for 12 weeks
|
Experimental: Supplement
Omega-3 capsules
|
Omega-3 capsules three times a week for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatty acids
Time Frame: 12 weeks
|
Levels of fatty acids in red blood cells before and after the intervention
|
12 weeks
|
Vitamin D status
Time Frame: 12 weeks
|
Levels of 25-hydroxy vitamin D in serum blood before and after the intervention
|
12 weeks
|
Mental health
Time Frame: 12 weeks
|
Mental health status measured by the Strengths and difficulties questionnaire (SDQ)
|
12 weeks
|
Iodine
Time Frame: 12 weeks
|
Levels of iodine in urine samples before and after the intervention
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ingvild Eide Graff, PhD, NIFES, PO Box 2029 Nordnes, N-5817 Bergen, Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Handeland 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
January 19, 2015
First Submitted That Met QC Criteria
January 25, 2015
First Posted (Estimate)
January 29, 2015
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 11, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- FHF 900842 WP6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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