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

NCT01750307 | Unknown DMC

• 1 other identifier: OCEAN protocol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Changes in cognitive and electrophysiological function (neuronal activity) will be found following supplementation with dietary EFAs.
2. 2.Changes in cognition and/or brain activity will be related to blood levels of EFAs.
3. 3.Changes in cognitive performance and electrophysiological parameters will correlate with behavioural function, affective regulation or functional impairments.
4. 4.At baseline, case-control differences in EFA blood-levels will be found which will be linked to cognitive and electrophysiological function.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The relationship of essential fatty acids to ADHD

  0 months

Study Arms (2)

Fatty acid supplementation

EXPERIMENTAL

4 capsules to be taken daily

Dietary Supplement: Experimental fatty acid supplementation

Medium Chain Triglyceride (MCT) oil softgel

PLACEBO COMPARATOR

4 capsules to be taken daily

Dietary Supplement: Placebo comparator: MCT oil softgel

Interventions

Experimental fatty acid supplementation DIETARY_SUPPLEMENT

4 x capsules per day. Daily dose: 1584mg EFA

Also known as: Essential fatty acid: Eye Q triple (product code: FO-5274ART)

Fatty acid supplementation

Placebo comparator: MCT oil softgel DIETARY_SUPPLEMENT

4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill

Also known as: MCT oil softgel (Product code: GL-5200ART)

Medium Chain Triglyceride (MCT) oil softgel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Cases:
• Clinical diagnosis of ADHD (combined or inattentive type)
• Controls:
• Screen below threshold for ADHD

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London

London, London, SE58AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Philip Asherson

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth E Cooper

CONTACT

+44 207 848 5401; ruth.cooper@kcl.ac.uk

Rose Scott

CONTACT

+44 207 848 5712; rose.scott@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

GB (1)