We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01075958
First Posted: February 25, 2010
Last Update Posted: September 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northumbria University
Results First Submitted: February 23, 2011  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Conditions: Attention
Memory
Mood
Mental Fatigue

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants from whom a venous blood sample could not be obtained were not entered into the analysis.

Reporting Groups
  Description
Healthy Participants Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.

Participant Flow:   Overall Study
    Healthy Participants
STARTED   283 
COMPLETED   239 
NOT COMPLETED   44 
Blood sample could not be obtained                44 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Participants Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.

Baseline Measures
   Healthy Participants 
Overall Participants Analyzed 
[Units: Participants]
 283 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   283 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.47  (3.95) 
Gender 
[Units: Participants]
 
Female   187 
Male   96 
Region of Enrollment 
[Units: Participants]
 
United Kingdom   283 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Simple Reaction Time (Attention)   [ Time Frame: Single visit ]

2.  Primary:   Choice Reaction Time (Attention)   [ Time Frame: Single visit ]

3.  Primary:   Four Choice Reaction Time (Attention)   [ Time Frame: Single visit ]

4.  Primary:   Numeric Working Memory (Working Memory)   [ Time Frame: Single visit ]

5.  Primary:   Alphabetic Working Memory (Working Memory)   [ Time Frame: Single visit ]

6.  Primary:   Corsi Blocks Span (Spatial Working Memory)   [ Time Frame: Single visit ]

7.  Primary:   3-back Task (Working Memory)   [ Time Frame: Single visit ]

8.  Primary:   Immediate Word Recall (Episodic Memory)   [ Time Frame: Single visit ]

9.  Primary:   Delayed Word Recall (Episodic Memory)   [ Time Frame: Single visit ]

10.  Primary:   Word Recognition (Episodic Memory)   [ Time Frame: Single visit ]

11.  Secondary:   Depression, Anxiety and Stress Scale (DASS)   [ Time Frame: Single visit-90 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Philippa Jackson
Organization: Northumbria University
phone: +44 191 204 8818
e-mail: philippa.jackson@northumbria.ac.uk



Responsible Party: Philippa Jackson, Northumbria University
ClinicalTrials.gov Identifier: NCT01075958     History of Changes
Other Study ID Numbers: 16N3
First Submitted: February 24, 2010
First Posted: February 25, 2010
Results First Submitted: February 23, 2011
Results First Posted: September 2, 2011
Last Update Posted: September 2, 2011