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Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.

NCT02346773 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-12-09

No results posted yet for this study

Summary

Currently, there is considerable interest in the possibility that dietary supplementation with fatty acids, mostly omega-3 fatty acids, will have potential benefits for brain development. Epidemiological and clinical studies support the idea that relative disappearance of omega-3 diet from the diet in developed countries has been linked with increases in both physical and mental disorders. Omega-3 deficiency may lead to cognitive impairment, motor dysfunction and visual acuity problems. It is further known that families with lower socioeconomic status may have poorer diet and, consequently, may not realize their full potential regarding their cognitive abilities. The aim of this project is to evaluate effectiveness of a diet intervention rich in omega-3 acid in healthy children 9-to-12 years old from less well-off families.

Conditions

  • Behaviour

Interventions

DIETARY_SUPPLEMENT

ω-3 LC-PUFA

The intervention product was a full fat (80%) margarine.Participants were provided with one-month supply of the intervention product (including reserve products) at the onset of the intervention and received a new supply monthly. The intervention products were provided in neutral serving-sized cups, each containing 10 grams of margarine.The child's parents were instructed to have their child consume one complete portion pack (10 g) of margarine per day. The margarine had to be consumed as spread on sandwiches, crackers or bread rolls.The intervention product could be consumed on various periods over the day or all at one occasion. Every day a new portion pack had to be used, even if there was margarine left in the package of the previous day.

OTHER

Placebo

The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products.

Sponsors & Collaborators

  • Unilever R&D

    collaborator INDUSTRY

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Tomáš Paus, M.D., Ph.D. · Rotman Research Institute, University of Toronto, Toronto, Canada

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346773 on ClinicalTrials.gov