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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01075958
Other study ID # 16N3
Secondary ID
Status Completed
Phase N/A
First received February 24, 2010
Last updated August 2, 2011
Start date July 2007
Est. completion date September 2008

Study information

Verified date August 2011
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 283
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Male/Female

- 18-35 years

- Healthy

- No herbal supplements/prescription medications (excl. contraceptive pill)

- Non smoker

- Native English speaker

Exclusion Criteria:

- BMI = 30

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Northumbria University Newcastle upon Tyne Tyne and Wear

Sponsors (1)

Lead Sponsor Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Single visit No
Primary 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. Single visit No
Primary 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. Single visit No
Primary Numeric Working Memory (Working Memory) Single visit No
Primary 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. Single visit No
Primary 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. Single visit No
Primary 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. Single visit No
Primary 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. Single visit No
Primary Delayed Word Recall (Episodic Memory) The participant was again given 60 seconds to write down as many of the words presented previously as possible. Single visit No
Primary 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. Single visit No
Secondary 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). Single visit-90 minutes No
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