Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child in target age (9-12 yrs)
- •Child native language English
- •Child is available for providing a blood sample
- •Child is available for MRI scan
排除标准
- •eating fatty fish/shellfish more than once a week;
- •using ω-3 and/or ω-6 LC-PUFA supplements more than once a week;
- •consuming products fortified with ω-3 LC-PUFA (EPA and/or DHA >100 mg/day) in the three months prior to study participation;
- •positive history of alcohol abuse during pregnancy;
- •positive history of malignancy and heart disease requiring heart surgery;
- •Premature birth (< 35 weeks) and/or detached placenta
- •Hyperbilirubinemia requiring transfusion
- •severe mental illness (e.g. autism, schizophrenia) or mental retardation;
- •MRI contraindications
- •Type 1 diabetes
- •Epilepsy
- •Brain tumour
- •Head trauma with loss of consciousness >30 minutes
- •Muscular dystrophy, myotonic dystrophy
- •Nutritional and metabolic diseases (e.g. failure to thrive, phenylketonuria)
- •Hearing deficit (requiring hearing aid)
结局指标
主要结局
Multi-modal Magnetic Resonance Imaging (MRI): Investigating the effects of three months of EPA&DHA supplementation on brain structure of healthy children 9-to-12 years old.
时间窗: Change from baseline MRI measures (DTI, MTR, MRS) at 3 months
次要结局
- Cognitive assessment as measured by neuropsychological testing(Change from baseline cognitive assessment at 3 months)