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

December 17, 2012 updated by: Philip Asherson, King's College London

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE58AF
        • Recruiting
        • Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philip Asherson
        • Sub-Investigator:
          • Ruth Cooper

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • MCT oil softgel (Product code: GL-5200ART)

What is the study measuring?

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
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Investigators

  • Principal Investigator: Philip Asherson, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCEAN protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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