Fish Oil and Muscle Function
| Tracking Information | |||||
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| First Received Date ICMJE | February 25, 2011 | ||||
| Last Updated Date | April 11, 2013 | ||||
| Start Date ICMJE | June 2011 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01308957 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Fish Oil and Muscle Function | ||||
| Official Title ICMJE | Omega-3 Fatty Acids, Muscle Mass and Muscle Function | ||||
| Brief Summary | The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on changes in muscle mass, muscular strength and physical function. |
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| Detailed Description | Loss of muscle mass is a normal consequence of aging in many older adults, worsened by chronic illness, poor appetite and diet, and reduced physical activity. The ensuing decline in physical function is a major cause of frailty, disability and death. Treatments that can reverse or reduce the age-associated loss of muscle mass are therefore much needed. Evidence is emerging that consumption of fish or fish oil derived long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) may be important for maintenance of muscle mass and physical function throughout the life-span. However, the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and overall physical function is not known. The goal of this study therefore is to determine the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and physical function in frail, older adults. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Sarcopenia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | March 2014 | ||||
| Estimated Primary Completion Date | March 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years to 85 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01308957 | ||||
| Other Study ID Numbers ICMJE | 201012999 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Washington University School of Medicine | ||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||
| Verification Date | April 2013 | ||||
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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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