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The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers

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ClinicalTrials.gov Identifier: NCT00805870
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Christopher Cheatham, Western Michigan University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Muscle Damage Muscle Inflammation Drug: Lovaza (omega-3-acid ethyl esters) Drug: Wheat Germ Oil Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Study Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fish Oil
Lovaza, 3 grams/day for 65 days
 Drug: Lovaza (omega-3-acid ethyl esters)
Lovaza, 3 grams per day for 65 days
Placebo Comparator: Control
Wheat Germ Oil, 3 grams/day for 65 days
 Drug: Wheat Germ Oil
Wheat germ oil, 3 grams/day for 65 days


Outcome Measures
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Primary Outcome Measures :
  1. Quadriceps Muscle Strength [ Time Frame: 6 days ]
    Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.

  2. Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge [ Time Frame: 6 days ]
    The required amount of force applied to the quadriceps to elicit pain or discomfort.

  3. Creatine Kinase Activity Measured in Blood [ Time Frame: 6 days ]
    Creatine kinase activity is an indirect indicator of muscle damage.

  4. Interleukin-6 Measured in Blood [ Time Frame: 6 days ]
    Interleukin-6 is an indirect indicator of muscle inflammation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805870


Locations
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United States, Michigan
Western Michigan University
Kalamazoo, Michigan, United States, 49008
Sponsors and Collaborators
Western Michigan University
GlaxoSmithKline
Investigators
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Principal Investigator: Christopher C Cheatham, Ph.D. Western Michigan University
More Information
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Responsible Party: Christopher Cheatham, Chair and Associate Professor, Western Michigan University
ClinicalTrials.gov Identifier: NCT00805870    
Other Study ID Numbers: 08-02-31
First Posted: December 10, 2008    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Myalgia
Myositis
Inflammation
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations