Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: 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  
Number of Participants  
[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


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