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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Inflammation; Muscle Damage
• Intervention / Treatment: Drug: Lovaza (omega-3-acid ethyl esters); Drug: Wheat Germ Oil

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Muscle Strength	Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.	6 days
Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge	The required amount of force applied to the quadriceps to elicit pain or discomfort.	6 days
Creatine Kinase Activity Measured in Blood	Creatine kinase activity is an indirect indicator of muscle damage.	6 days
Interleukin-6 Measured in Blood	Interleukin-6 is an indirect indicator of muscle inflammation.	6 days

Collaborators and Investigators

• Sponsor: Western Michigan University
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Christopher C Cheatham, Ph.D., Western Michigan University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: August 1, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Inflammation; Myositis
• Other Study ID Numbers: 08-02-31