Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults
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| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2010 | ||||
| Last Updated Date | August 2, 2011 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Cognitive function and mood [ Time Frame: Single visit ] [ Designated as safety issue: No ] Participants will attend one session where cognitive performance and mood will be assessed |
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| Change History | Complete list of historical versions of study NCT01075958 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Polyunsaturated Fatty Acids (PUFA) Status and Cognitive Function in Healthy Young Adults | ||||
| Official Title ICMJE | The Relationship Between Serum PUFAs and Cognitive Function in Healthy Young Adults | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Serum |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 283 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01075958 | ||||
| Other Study ID Numbers ICMJE | 16N3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Philippa Jackson, Northumbria University | ||||
| Study Sponsor ICMJE | Northumbria University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northumbria University | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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