Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.

Mental Health Clinical Trial

Official title:

Food2Learn: Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240264
• Other study ID #: Food2Learn
• Secondary ID: 13-T-115
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: April 5, 2017
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Open University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The brain is primarily developed in the third trimester of pregnancy, but continues maturing through the late twenties, especially the prefrontal cortex. Omega-3 long-chain polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell membranes, influence membrane fluidity and signal transduction, and thus learning, cognition and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with limitations in these complex brain functions. Previous studies suggested that such functions could be improved by increasing LCPUFA. The adolescent brain, however, has been largely neglected. This study investigates the effect of one-year daily omega-3 LCPUFA supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be adjusted individually to reach a target level of 8-11%. The effects on learning (academic achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation, goal-orientation, absenteeism), and in a subsample cognitive processes, in particular perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months. This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a safe intervention, on a large variety of complex brain functions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria:

• Healthy adolescents aged 14-15 years.

• In lower general secondary education (MAVO/VMBO).

Exclusion Criteria:

• Suffering from hemophilia (blood clotting disorder).

• Allergic to (shell)fish.

Related Conditions & MeSH terms

• Academic Performance
• Cognitive Function
• Mental Health

Intervention

Dietary Supplement:
• Krill oil capsules
1 year supplementation with Krill oil provided by Aker BioMarine Antarctic AS equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.
• Placebo
Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.

Locations

Country	Name	City	State
Netherlands	De Nassau	Breda	Brabant
Netherlands	Graaf Engelbrecht	Breda	Brabant
Netherlands	Newman College	Breda	Brabant
Netherlands	Stabrecht College	Geldrop
Netherlands	Graaf Huyn College	Geleen
Netherlands	Scholengemeenschap Sophianum	Gulpen
Netherlands	Citaverde	Heerlen
Netherlands	Grotius College	Heerlen
Netherlands	Sintermeertencollege	Heerlen
Netherlands	Dr.Knippenberg College	Helmond	Noord Brabant
Netherlands	Beroepscollege Holz	Kerkrade
Netherlands	Canisius College	Nijmegen	Gelderland
Netherlands	Bouwens van der Boijecollege	Panningen
Netherlands	MAVO Roermond	Roermond	Limburg
Netherlands	DaCapo College	Sittard
Netherlands	Stella Maris College	Valkenburg
Netherlands	Colllege Den Hulster	Venlo

Sponsors (5)

Lead Sponsor	Collaborator
Open University	Aker Biomarine Antarctic AS, Metrisquare, Netherlands Organisation for Scientific Research, Omegametrix GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance	Neuropsychological tests covering seceral executive functions (LDST, D2, CST, Stroop, Digit Span).	12 months
Secondary	Eye tracking	Two types of eye tracking parameters will be calculated, namely basic parameters and paragraph-related parameters. Basic parameters are number of blinks, number of fixations, total duration of fixations, average fixation duration, average dispersion of fixation positions, average saccadic amplitude, and average saccadic velocity. Moreover, we will calculate eye tracking measures per paragraph, namely time spent on each paragraph (number and duration of fixations), time elapsed until first looking at a paragraph, and amount of times going back to a paragraph (revisits).	12 months
Secondary	Academic achievement	Grade point average for Dutch, English and mathematics and standardized mathematics test scores (AMN).	12 months
Secondary	Behaviour: absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem	Absenteeism, motivation (MSLQ), Mood (CES-D), Self-esteem	12 months
Secondary	Sleep duration and sleep quality	Sleep duration measured using ActivPAL and diary, Sleep quality determined using the adolescent sleep wake scale (ASWS) and the adolescent sleep hygiene scale (ASHS).	12 months

External Links

•   Project page to inform participants and parents/legual guardians.