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The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
This study is currently recruiting participants.
Verified by Western Michigan University, March 2009
First Received: December 9, 2008   Last Updated: March 17, 2009   History of Changes
Sponsors and Collaborators: Western Michigan University
GlaxoSmithKline
Information provided by: Western Michigan University
ClinicalTrials.gov Identifier: NCT00805870
  Purpose

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

MedlinePlus related topics: Dietary Supplements Myositis
Drug Information available for: Omacor Fish oil
U.S. FDA Resources
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

Further study details as provided by Western Michigan University:

Primary Outcome Measures:
  • Muscle strength of the quadriceps [ Time Frame: Each of Days 60-65 ] [ Designated as safety issue: No ]
  • Muscle soreness of the quadriceps using a visual analog scale and an algometer strain gauge [ Time Frame: Each of Days 60-65 ] [ Designated as safety issue: No ]
  • Creatine Kinase Activity measured in blood [ Time Frame: Each of Days 60-65 ] [ Designated as safety issue: No ]
  • Muscle inflammatory markers (Tumor Necrosis Factor, Interleukin-1, Interleukin-6) measured in blood [ Time Frame: Each of Days 60-65 ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, free of disease
  • Must be able to swallow capsules
  • Free of orthopedic or muscular injuries
  • Recreationally active
  • Prior consumption of fish and corn with no adverse reactions

Exclusion Criteria:

  • Use of non-steroidal anti-inflammatory drugs (NSAIDS) or topical analgesics during study enrollment
  • Pregnant or nursing
  • Food allergy to fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or wheat germ oil
  • Competitive athlete or physically active more than 10 hours per week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805870

Contacts
Contact: Christopher C Cheatham, Ph.D. (269) 387-2542 chris.cheatham@wmich.edu

Locations
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.            
Sponsors and Collaborators
Western Michigan University
GlaxoSmithKline
Investigators
Principal Investigator: Christopher C Cheatham, Ph.D. Western Michigan University
  More Information

No publications provided

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

Study placed in the following topic categories:
Myositis
Idiopathic Myopathy
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Inflammation

Additional relevant MeSH terms:
Myositis
Muscular Diseases
Pathologic Processes
Neuromuscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Inflammation

ClinicalTrials.gov processed this record on May 07, 2009