Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults

This study has been completed.
Sponsor:
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01075958
First received: February 24, 2010
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition
Attention
Memory
Mood
Mental Fatigue

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults

Resource links provided by NLM:


Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Simple Reaction Time (Attention) [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Alphabetic Working Memory (Working Memory) [ Time Frame: Single visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Depression, Anxiety and Stress Scale (DASS) [ Time Frame: Single visit-90 minutes ] [ Designated as safety issue: No ]
    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).


Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 283
Study Start Date: July 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The sample will be drawn from a student and professional population in the Newcastle upon Tyne area in the UK

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075958

Locations
United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Investigators
Principal Investigator: Philippa A Jackson Northumbria University
  More Information

Additional Information:
No publications provided

Responsible Party: Philippa Jackson, Northumbria University
ClinicalTrials.gov Identifier: NCT01075958     History of Changes
Other Study ID Numbers: 16N3
Study First Received: February 24, 2010
Results First Received: February 23, 2011
Last Updated: August 2, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Northumbria University:
n-3 PUFAs
Fish oil
Cognitive function
Healthy young adults

Additional relevant MeSH terms:
Mental Fatigue
Fatigue
Signs and Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014