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

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Experimental fatty acid supplementation
Placebo comparator: MCT oil softgel
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring 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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fatty acid supplementation

Medium Chain Triglyceride (MCT) oil softgel

Arm Description

4 capsules to be taken daily

4 capsules to be taken daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 12, 2012
Last Updated
December 17, 2012
Sponsor
King's College London
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1. Study Identification

Unique Protocol Identification Number
NCT01750307
Brief Title
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
Acronym
OCEAN
Official Title
The Relationship of Essential Fatty Acids to Cognitive Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fatty acid supplementation
Arm Type
Experimental
Arm Description
4 capsules to be taken daily
Arm Title
Medium Chain Triglyceride (MCT) oil softgel
Arm Type
Placebo Comparator
Arm Description
4 capsules to be taken daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental fatty acid supplementation
Other Intervention Name(s)
Essential fatty acid: Eye Q triple (product code: FO-5274ART)
Intervention Description
4 x capsules per day. Daily dose: 1584mg EFA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo comparator: MCT oil softgel
Other Intervention Name(s)
MCT oil softgel (Product code: GL-5200ART)
Intervention Description
4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill
Primary Outcome Measure Information:
Title
The relationship of essential fatty acids to cognitive and electrophysiological measures of brain and behavioural function
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The relationship of essential fatty acids to ADHD
Description
This will be assessed by recording blood levels of EFAs in cases and controls at baseline assessment.
Time Frame
0 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth E Cooper
Phone
+44 207 848 5401
Email
ruth.cooper@kcl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Rose Scott
Phone
+44 207 848 5712
Email
rose.scott@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Asherson
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Social, genetic and developmental psychiatry, Institute of Psychiatry, King's College London
City
London
ZIP/Postal Code
SE58AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth E Cooper
Phone
+44 207 848 5401
Email
ruth.cooper@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Rose Scott
Phone
+44 207 848 5712
Email
rose.scott@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Philip Asherson
First Name & Middle Initial & Last Name & Degree
Ruth Cooper

12. IPD Sharing Statement

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

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