Behaviour Clinical Trial
Official title:
Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
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.
Background It has been established that a safe environment, adequate stimulation, and
parental care play a major role in brain development. An adequate diet is also critically
important for brain development in growing children. It has been suggested that omega-3
fatty acids are essential to human health as well as cognitive development. Omega-3 acid is
important during prenatal human brain development, especially for synaptogenesis. Levels of
omega-3 amino acids in during prenatal and early postnatal (breastfeeding) periods depend on
their levels in maternal circulation. Later on, omega-3 must be present in the child's diet.
It seems that omega-3 deficiency may associated with impaired visual acuity, cognition,
cerebellar dysfunction and other neurological disorders (Haag, 2003; Review). Thus, omega-3
supplementation may be beneficial in children with poor diet, often associated with a lower
socioeconomic level (Northstone et al. 2008).
Aims and Design We assessed effects of Omega-3 supplementation on brain and behaviour of 40
healthy children 9-to-12 years old. Since diet supplementation may be beneficial in
particular to children with poor diet, we recruited children in less well-off
neighbourhoods, as determined by the Index of Multiple Deprivation 2007. Our aim was to
examine differences on cognitive performance pre and post diet supplementation.
The brain structure was assessed using magnetic resonance imaging (MRI). Cognitive abilities
as well as behavioural problems were assessed using a comprehensive battery of tests and
questionnaires. To evaluate the effectiveness of the supplementation, we collected a blood
sample to investigate the fatty acids level in the blood. The above assessments were carried
out twice: before and after a 3-month dietary intervention.
The dietary intervention included a daily use, for a period of three months, of margarine
enriched (Experimental group) or not (placebo group) with Omega-3 fatty acids. We
hypothesized that this intervention will improve some cognitive deficits (such as attention,
processing speed) and behavioural symptoms (e.g. depression, aggressiveness, impulsivity)
together with an impact on brain structure (e.g. white-matter properties related to
myelination).
Experimental Protocol Each participant participated in two phases: a clinical assessment
phase (to assure exclusion and inclusion criteria) and an experimental phase. The
experimental phase consisted of the baseline (pre-intervention) assessment, the diet
intervention (3 months) and the post-intervention assessment.
At baseline, both groups (enriched diet and placebo) underwent a cognitive assessment and
MRI. Parents were asked to complete a questionnaire about the child's behaviour and some
demographical data such as number of children, education etc. Children were also asked to
provide a blood sample, which was taken by a fully trained and licensed team member.
After the baseline assessment, experimental group (n=20) and control group (n=20) followed a
diet supplementation with omega-3 fatty acids or placebo diet respectively. The intervention
lasted for three months and then the tests were re-administered for both groups (cases and
controls). Parents were also asked to complete a brief questionnaire to measure children's
behaviour.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
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