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Completed

NCT Number: NCT00805870

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Western Michigan University

Kalamazoo, Michigan, 49008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lovaza (omega-3-acid ethyl esters)

Drug

Lovaza, 3 grams per day for 65 days

Wheat Germ Oil

Drug

Wheat germ oil, 3 grams/day for 65 days

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Western Michigan University

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 10, 2008
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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