Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
Condition: Behaviour
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): ω-3 LC-PUFA; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)