Clinical trial NCT02350322: Diet and Learning Abilities in Norwegian Youths
Official title: Diet and Learning Abilities in Norwegian Youths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Health Behavior
Nutrient Status
Keywords: Diet
concentration
seafood
youths
Norway
Nutrient status in blood
Inflammatory markers
Lead sponsor: National Institute of Nutrition and Seafood Research, Norway
Sponsor class: OTHER_GOV
Collaborators: name: NORCE Norwegian Research Centre AS
name: University of Tromso
First posted: 2015-01-29
Enrollment: 478
Sex: ALL
Minimum age (years): 14
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration performance and literary skills
timeFrame: 12 weeks
Secondary outcomes:
measure: Fatty acids
timeFrame: 12 weeks
measure: Vitamin D status
timeFrame: 12 weeks
measure: Mental health
timeFrame: 12 weeks
measure: Iodine
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Lisbeth Dahl
Study officials:
affiliation: NIFES, PO Box 2029 Nordnes, N-5817 Bergen, Norway
name: Ingvild Eide Graff, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.