The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function
研究概览
简要总结
Brief summary
The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).
The study design will be a 6-month double blind placebo control study with a group of 80 adults with a diagnosis of ADHD. The group will be divided into 40 participants who receive EFA dietary supplements and 40 who receive placebo, over a 6-month period. Allocation to EFA dietary supplementation and placebo groups will be randomly allocated and blind to both the investigator and participants. In addition a sample of 30 controls will take part in baseline levels of assessment and be used for case-control comparisons to investigate the links between EFA blood levels and cognitive-electrophysiological function at one time point.
The study design will enable preliminary data to address the following hypotheses:
- Changes in cognitive and electrophysiological function (neuronal activity) will be found following supplementation with dietary EFAs.
- Changes in cognition and/or brain activity will be related to blood levels of EFAs.
- Changes in cognitive performance and electrophysiological parameters will correlate with behavioural function, affective regulation or functional impairments.
- At baseline, case-control differences in EFA blood-levels will be found which will be linked to cognitive and electrophysiological function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of ADHD (combined or inattentive type)
- •Controls:
- •Screen below threshold for ADHD
排除标准
- •Autism spectrum disorder
- •Recurrent major depression
- •Bipolar I disorder
- •Psychotic disorders
- •Obsessive compulsive disorder
- •Learning difficulties (IQ < 80)
- •Neurological problems
- •Drug abuse
- •Those who are already taking EFA supplements
- •Metabolic conditions
- •Infectious diseases
- •Controls:
- •All other exclusion criteria for cases as above
研究组 & 干预措施
Fatty acid supplementation
4 capsules to be taken daily
干预措施: Experimental fatty acid supplementation (Dietary Supplement)
Medium Chain Triglyceride (MCT) oil softgel
4 capsules to be taken daily
干预措施: Placebo comparator: MCT oil softgel (Dietary Supplement)
结局指标
主要结局
The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function
时间窗: 6 months
Brain function will be measured using direct current (DC) electroencephalography (EEG) in participants first while they are at rest and second during 4 cognitive tasks. Behavioural function will be measured through assessment of reading and spelling, emotional lability, ADHD symptoms and other self-ratings of behaviour (such as executive function). These measures will be related to the effect of dietary supplementation and blood levels of EFAs in adults with ADHD.
次要结局
- The relationship of essential fatty acids to ADHD(0 months)
研究者
Philip Asherson
Professor
King's College London