NCT02350322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 19, 2015

Last Update Submit

January 11, 2016

Conditions

Cognitive PerformanceHealth BehaviorNutrient Status

Keywords

DietconcentrationseafoodyouthsNorwayNutrient status in bloodInflammatory markers

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Fatty acids

    12 weeks

  • Vitamin D status

    12 weeks

  • Mental health

    12 weeks

  • Iodine

    12 weeks

Study Arms (3)

Schoolmeal with fatty fish

EXPERIMENTAL

Fatty fish diet

Other: Schoolmeal with fatty fish

Schoolmeal without fish

EXPERIMENTAL

Meat/cheese diet (non-seafood)

Other: Schoolmeal without fish

Supplement

EXPERIMENTAL

Omega-3 capsules

Dietary Supplement: Supplement

Interventions

Schoolmeal with fatty fishOTHER

Schoolmeal with fatty fish three times a week for 12 weeks

Schoolmeal with fatty fish
Schoolmeal without fishOTHER

Schoolmeal with meat/cheese three times a week for 12 weeks

Schoolmeal without fish
SupplementDIETARY_SUPPLEMENT

Omega-3 capsules three times a week for 12 weeks

Supplement

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • girls and boys at lower secondary schools (9th grade)

You may not qualify if:

  • allergy or intolerance to the food or food ingredients in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lisbeth Dahl

Bergen, 5004, Norway

Location

Related Publications (2)

  • 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.

    PMID: 29475446DERIVED

  • 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.

    PMID: 28969711DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

In Situ Hybridization, FluorescenceDietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ingvild Eide Graff, PhD

    NIFES, PO Box 2029 Nordnes, N-5817 Bergen, Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 29, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

NO(1)