Diet and Learning Abilities in Norwegian Youths

Health Behavior Clinical Trial

Official title:

Diet and Learning Abilities in Norwegian Youths

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350322
• Other study ID #: FHF 900842 WP6
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 11, 2016
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: National Institute of Nutrition and Seafood Research, Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical 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. In addition, to disentangle the effect of fatty fish eaten as food and the effects of omega-3 fatty acids taken as a supplement.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cognitive Performance
• Health Behavior
• Nutrient Status

Intervention

Other:
• Schoolmeal with fatty fish
Schoolmeal with fatty fish three times a week for 12 weeks
• Schoolmeal without fish
Schoolmeal with meat/cheese three times a week for 12 weeks

Dietary Supplement:
• Supplement
Omega-3 capsules three times a week for 12 weeks

Locations

Country	Name	City	State
Norway	Lisbeth Dahl	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Nutrition and Seafood Research, Norway	Uni Research, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	Fatty acids	Levels of fatty acids in red blood cells before and after the intervention	12 weeks	No
Secondary	Vitamin D status	Levels of 25-hydroxy vitamin D in serum blood before and after the intervention	12 weeks	No
Secondary	Mental health	Mental health status measured by the Strengths and difficulties questionnaire (SDQ)	12 weeks	No
Secondary	Iodine	Levels of iodine in urine samples before and after the intervention	12 weeks	No