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| Tracking Information | |||||
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| First Received Date ICMJE | October 10, 2006 | ||||
| Last Updated Date | September 19, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00385723 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
stress-related increases in cytokine production and negative mood following laboratory stressors [ Time Frame: Baseline & 4 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fish Oil (Omega 3), Immune Function, and Mood | ||||
| Official Title ICMJE | Omega-3 Dietary Supplementation, Immune Function, and Mood | ||||
| Brief Summary | This study is designed to examine the effects of fish oil on immune function and mood. |
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| Detailed Description | The beneficial effects of fish oil (or eating fish more frequently) include reductions in triglycerides, blood pressure, and heart rate, as well as increases in HDL cholesterol, the "good" type of cholesterol. In addition, certain aspects of immune function also appear to show favorable responses to fish oil supplementation, and some studies suggest that fish oil helps to improve mood and decrease depression. This study is designed to examine how supplementation with omega-3 polyunsaturated fatty acids (key fish oil components) affects aspects of your immune response, and your mood; because some research suggests that people who eat more fish may do better during stressful times, the study will also examine how fish oil affects your immune response to stress, certain stress hormone responses, and your psychological response to stress. For detailed information about the study, please visit our website at http://www.stressandhealth.org |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Inflammation | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 138 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Recruiting men and women ages 50-80 from the Greater Columbus Ohio area. Participation involves taking capsules for 4 months and completing 7 appointments (for a total of 17 hours) at Ohio State. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00385723 | ||||
| Responsible Party | Janice Kiecolt-Glaser, PhD, Ohio State University College of Medicine | ||||
| Study ID Numbers ICMJE | AG0087, 2006H0054, R01 AG029562 | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | Ohio State University | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | September 2008 | ||||
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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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