The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)

Study Overview
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Brief Summary
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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.

Official Title
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The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Dietary Supplement: Experimental fatty acid supplementation
* Dietary Supplement: Placebo comparator: MCT oil softgel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases: Clinical diagnosis of ADHD (combined or inattentive type) Controls: Screen below threshold for ADHD Exclusion Criteria: Cases: 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: ADHD All other exclusion criteria for cases as above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatty acid supplementation<br>4 capsules to be taken daily | Dietary Supplement: Experimental fatty acid supplementation<br>* 4 x capsules per day. Daily dose: 1584mg EFA<br>* Other names: Essential fatty acid: Eye Q triple (product code: FO-5274ART);|
| Placebo Comparator: Medium Chain Triglyceride (MCT) oil softgel<br>4 capsules to be taken daily | Dietary Supplement: Placebo comparator: MCT oil softgel<br>* 4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill<br>* Other names: MCT oil softgel (Product code: GL-5200ART);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of essential fatty acids to ADHD | This will be assessed by recording blood levels of EFAs in cases and controls at baseline assessment. | 0 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder (ADHD), Essential fatty acids (EFAs), Electroencephalography (EEG), Event-related potential (ERP), Omega 3, Randomised Control Trial, Fish oil, Supplementation, Reading, Spelling, Behaviour, Emotional lability