Trial Outcomes & Findings for Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults (NCT NCT01075958)

NCT ID: NCT01075958

Last Updated: 2011-09-02

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 283 participants
• Primary outcome timeframe: Single visit
• Results posted on: 2011-09-02

Participant Flow

Recruitment took place on the Northumbria University campus via posted adverts and email messages sent using the university distribution lists. Recruitment took place in 2 waves; the first taking place between July 31 - November 8 2007, and the second between March 26 - September 9 2008.

Participants from whom a venous blood sample could not be obtained were not entered into the analysis.

Participant milestones

Measure	Healthy Participants Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
Overall Study STARTED	283
Overall Study COMPLETED	239
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Measure	Healthy Participants Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
Overall Study Blood sample could not be obtained	44

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy Participants n=283 Participants Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	283 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	22.47 years STANDARD_DEVIATION 3.95 • n=5 Participants
Sex: Female, Male Female	187 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants
Region of Enrollment United Kingdom	283 participants n=5 Participants

PRIMARY outcome

Timeframe: Single visit

Population: Only those participants for whom a venous blood sample was obtained (N=239) were entered into the analysis. A further 20 participants were excluded on the basis that their BMI exceeded 30, and could not be considered 'healthy individuals'.

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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Simple Reaction Time (Attention)	287.7 ms Standard Error 2.67

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Choice Reaction Time (Attention)	412.79 ms Standard Error 3.75

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Four Choice Reaction Time (Attention)	499.52 ms Standard Error 5.84

PRIMARY outcome

Timeframe: Single visit

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Numeric Working Memory (Working Memory)	95.57 percent of correct responses Standard Error 0.34

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Alphabetic Working Memory (Working Memory)	94.5 percent of correct responses Standard Error 0.30

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Corsi Blocks Span (Spatial Working Memory)	5.90 Blocks remembered in sequence Standard Error 0.08

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
3-back Task (Working Memory)	80.89 percent of correct responses Standard Error 1.04

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Immediate Word Recall (Episodic Memory)	6.21 Number of words recalled Standard Error 0.16

PRIMARY outcome

Timeframe: Single visit

The participant was again given 60 seconds to write down as many of the words presented previously as possible.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Delayed Word Recall (Episodic Memory)	4.73 Number of words recalled Standard Error 0.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Word Recognition (Episodic Memory)	80.35 percent of correct responses Standard Error 0.68

SECONDARY outcome

Timeframe: Single visit-90 minutes

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).

Outcome measures

Measure	Healthy Participants n=219 Participants All eligible participants.
Depression, Anxiety and Stress Scale (DASS)	22.45 Scores on a scale Standard Deviation 16.70

Adverse Events

Healthy Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Philippa Jackson

Northumbria University

Phone: +44 191 204 8818

Email: philippa.jackson@northumbria.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place