The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment) (OCEAN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01750307|
Recruitment Status : Unknown
Verified December 2012 by Philip Asherson, King's College London.
Recruitment status was: Recruiting
First Posted : December 17, 2012
Last Update Posted : December 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder (ADHD)||Dietary Supplement: Experimental fatty acid supplementation Dietary Supplement: Placebo comparator: MCT oil softgel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2015|
Experimental: Fatty acid supplementation
4 capsules to be taken daily
Dietary Supplement: Experimental fatty acid supplementation
4 x capsules per day. Daily dose: 1584mg EFA
Other Name: Essential fatty acid: Eye Q triple (product code: FO-5274ART)
Placebo Comparator: Medium Chain Triglyceride (MCT) oil softgel
4 capsules to be taken daily
Dietary Supplement: Placebo comparator: MCT oil softgel
4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill
Other Name: MCT oil softgel (Product code: GL-5200ART)
- The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function [ Time Frame: 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.
- The relationship of essential fatty acids to ADHD [ Time Frame: 0 months ]This will be assessed by recording blood levels of EFAs in cases and controls at baseline assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750307
|Contact: Ruth E Cooper||+44 207 848 firstname.lastname@example.org|
|Contact: Rose Scott||+44 207 848 email@example.com|
|Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London||Recruiting|
|London, United Kingdom, SE58AF|
|Contact: Ruth E Cooper +44 207 848 5401 firstname.lastname@example.org|
|Contact: Rose Scott +44 207 848 5712 email@example.com|
|Principal Investigator: Philip Asherson|
|Sub-Investigator: Ruth Cooper|
|Principal Investigator:||Philip Asherson||King's College London|