AttentionNCT01075958
Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
An observational study of Attention and Memory, run by Northumbria University at 1 site in United Kingdom.
Trial summary
To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in cognitively intact individuals has only been examined in a limited number of studies; it is at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and mood in this population. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- How many people
- 283 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Sep 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
Who may be able to join
- Male/Female
- 18-35 years
- Healthy
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
- Native English speaker
Who cannot join
- BMI ≥ 30
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults
To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in cognitively intact individuals has only been examined in a limited number of studies; it is at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and mood in this population. Further to this, it still remains to be established whether a relationship exists between peripheral fatty acid status-reflective of dietary n-3 PUFA intake-and cognitive function in this population. The current study therefore aims to address this issue by exploring the relationship between serum PUFAs and specific cognitive functions in a sample of healthy adults. To this end, participants will complete a range of cognitive tasks evaluating performance across the domains of attention, memory and executive function. Self-report mood assessments will be included as secondary measures.
- Conditions
- Attention, Memory, Mood, Mental Fatigue
- Keywords
- n-3 PUFAs, Fish oil, Cognitive function, Healthy young adults
- Medical subject headings
- Mental Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Reaction Time (Attention)
The participant was instructed to press the 'space bar' on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.
Measured: Single visit
Choice Reaction Time (Attention)
An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.
Measured: Single visit
Four Choice Reaction Time (Attention)
A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows 'lit up' at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.
Measured: Single visit
Numeric Working Memory (Working Memory)
Measured: Single visit
Alphabetic Working Memory (Working Memory)
Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.
Measured: Single visit
Corsi Blocks Span (Spatial Working Memory)
In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.
Measured: Single visit
3-back Task (Working Memory)
A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.
Measured: Single visit
Immediate Word Recall (Episodic Memory)
A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.
Measured: Single visit
Delayed Word Recall (Episodic Memory)
The participant was again given 60 seconds to write down as many of the words presented previously as possible.
Measured: Single visit
Word Recognition (Episodic Memory)
The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate 'yes' and 'no' keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.
Measured: Single visit
Secondary outcomes (1)
Depression, Anxiety and Stress Scale (DASS)
The DASS is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS scales contains 14 items. Subjects are asked to use 4-point (0-3) severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress (0-42) are calculated by summing the scores for the relevant items, with higher scores indicating higher incidence of negative emotional symptoms. A total score can be derived by adding scores from each of the subscales (0-126).
Measured: Single visit-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Investigators
- Philippa A Jackson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075958
- Sponsor's protocol ID
- 16N3
- Status last verified
- Aug 2011
- First submitted
- 24 Feb 2010
- Last updated
- 2 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT01075958
- Acronym / sponsor ID
- 16N3
- Conditions
- Attention, Memory, Mood, Mental Fatigue
- Keywords
- n-3 PUFAs, Fish oil, Cognitive function, Healthy young adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, the relationship between omega-3 polyunsaturated fatty acids (n-3 PUFAs) in cognitively intact individuals has only been examined in a limited number of studies; it is at present unknown whether supplementation with n-3 PUFAs can improve cognitive function and mood in this population. Further to this, it still remains to be established whether a relationship exists between peripheral fatty acid status-reflective of dietary n-3 PUFA intake-and cognitive function in this population. The current study therefore aims to address this issue by exploring the relationship between serum PUFAs and specific cognitive functions in a sample of healthy adults. To this end, participants will complete a range of cognitive tasks evaluating performance across the domains of attention, memory and executive function. Self-report mood assessments will be included as secondary measures.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK
Key inclusion criteria (6 listed)
- Male/Female
- 18-35 years
- Healthy
- No herbal supplements/prescription medications (excl. contraceptive pill)
- Non smoker
Key exclusion criteria (1 listed)
- BMI ≥ 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Simple Reaction Time (Attention)
Time frame: Single visit
The participant was instructed to press the 'space bar' on the laptop keyboard as quickly as possible every time an upwards pointing arrow appeared on screen. Fifty stimuli were presented with an inter-stimulus duration that varied randomly between 1 and 3.5 seconds.
Choice Reaction Time (Attention)
Time frame: Single visit
An arrow appeared on the screen pointing to the left or to the right. Participants responded with a left or right key press corresponding to the direction of the arrow. There was a randomly varying inter-stimulus interval of between 1 and 3 seconds for a total of fifty stimuli.
Four Choice Reaction Time (Attention)
Time frame: Single visit
A visual representation of the four direction arrow keys of a standard keyboard was presented on screen. The arrows 'lit up' at random on screen until the corresponding key press was made. In all, each arrow was the target stimulus 12 times, forming a total of 48 stimuli for this task in all.
Numeric Working Memory (Working Memory)
Time frame: Single visit
Alphabetic Working Memory (Working Memory)
Time frame: Single visit
Five random letters (A-Z) were presented sequentially for the participant to hold in memory. This was followed by a series of 30 probe digits (15 targets and 15 distractors) for each of which the participant indicated whether or not it had been in the original series by a simple key press. The task consisted of 3 separate trials.
Corsi Blocks Span (Spatial Working Memory)
Time frame: Single visit
In this task nine identical blue squares appeared on screen in non-overlapping random positions. A set number of blocks changed colour from blue to red in a randomly generated sequence. Participants were instructed to repeat the sequence by clicking on the blocks using the mouse and cursor. The task was repeated five times at each level of difficulty. The sequence span increased from 4, until the participant could no longer correctly recall the sequence, resulting in a span measure of nonverbal working memory, calculated by averaging the level of the last five correctly completed trials.
3-back Task (Working Memory)
Time frame: Single visit
A continuous string of letters (upper and lower case; inter-stimulus interval of 2.5 seconds) was presented; 45 letters in total with 15 target pairs. For each stimulus, participants were instructed to indicate whether this was the same letter that appeared three letters before.
Immediate Word Recall (Episodic Memory)
Time frame: Single visit
A unique set of fifteen words is presented. Words were selected at random from a large bank of words derived from the MRC Psycholinguistic Database matched for word length, frequency, familiarity and concreteness. Stimulus duration was one second, as was the inter-stimulus duration. Following word presentation, the participant was allowed 60 seconds to write down as many of the words as possible.
Delayed Word Recall (Episodic Memory)
Time frame: Single visit
The participant was again given 60 seconds to write down as many of the words presented previously as possible.
Word Recognition (Episodic Memory)
Time frame: Single visit
The original 15 words plus 15 distractor words were presented one at a time in a random order. For each word the participant indicated whether or not it was included in the original list of words by pressing appropriate 'yes' and 'no' keys as quickly as possible. Stimuli remained on screen until an appropriate response had been made.
1 secondary outcome
Depression, Anxiety and Stress Scale (DASS)
Time frame: Single visit-90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Brain, Performance and Nutrition Research Centre, Northumbria UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa A Jackson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention and Memory, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple Reaction Time (Attention) (time frame: Single visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.