Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Western Michigan University GlaxoSmithKline |
---|---|
Information provided by: | Western Michigan University |
ClinicalTrials.gov Identifier: | NCT00805870 |
The purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.
Condition | Intervention | Phase |
---|---|---|
Muscle Damage Muscle Soreness Muscle Inflammation |
Drug: Lovaza (omega-3-acid ethyl esters) Drug: Wheat Germ Oil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers |
Estimated Enrollment: | 30 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Lovaza, 3 grams/day for 65 days: Experimental |
Drug: Lovaza (omega-3-acid ethyl esters)
Lovaza, 3 grams per day for 65 days
|
Wheat Germ Oil, 3 grams/day for 65 days: Placebo Comparator |
Drug: Wheat Germ Oil
Wheat germ oil, 3 grams/day for 65 days
|
When a person exercises at a high intensity or starts a new exercise program, muscle soreness will develop. Muscle soreness that peaks between 24-72 hours after exercise and diminishes in 5-7 days is characterized as delayed onset muscle soreness (DOMS). DOMS is associated with the eccentric phase of exercise, where the muscle is actively creating force while lengthening. The onset of muscle soreness is part of an inflammatory response due to the muscular damage caused by the exercise.
Research has shown that fish oils have anti-inflammatory properties. Direct intake of various polyunsaturated fatty acids (PUFA) alters the cell membrane fatty acid composition, which, in turn modulates cell/tissue response to infection, injury and inflammatory events. These properties may be beneficial to relieve muscle soreness.
Therefore, the purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline, 3 grams per day for 65 days) on muscle strength, muscle soreness and inflammation following exercise.
Participants will be randomly assigned to one of two groups: Lovaza (3 grams/day) or placebo. Participants will consume either the Lovaza or the placebo for 65 consecutive days. On Day 60, participants will have baseline measurements of muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory marker assessed. Participants will then perform eccentric exercise on an isokinetic dynamometer using the quadriceps muscles in order to induce muscle soreness. On each of Days 61-65, muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory markers will again be assessed.
Ages Eligible for Study: | 18 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher C Cheatham, Ph.D. | (269) 387-2542 | chris.cheatham@wmich.edu |
United States, Michigan | |
Western Michigan University | Recruiting |
Kalamazoo, Michigan, United States, 49008 | |
Contact: Christopher C Cheatham, Ph.D. 269-387-2542 chris.cheatham@wmich.edu | |
Principal Investigator: Christopher C Cheatham, Ph.D. |
Principal Investigator: | Christopher C Cheatham, Ph.D. | Western Michigan University |
Responsible Party: | Western Michigan University ( Christopher C. Cheatham, Ph.D., Associate Professor of Exercise Science/Physiology ) |
Study ID Numbers: | 08-02-31 |
Study First Received: | December 9, 2008 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00805870 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Myositis Idiopathic Myopathy Muscular Diseases |
Neuromuscular Diseases Musculoskeletal Diseases Inflammation |
Myositis Muscular Diseases Pathologic Processes Neuromuscular Diseases |
Musculoskeletal Diseases Nervous System Diseases Inflammation |