Clinical trial NCT00805870: The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Official title: The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Damage
Muscle Inflammation
Lead sponsor: Western Michigan University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Quadriceps Muscle Strength
timeFrame: 6 days
measure: Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge
timeFrame: 6 days
measure: Creatine Kinase Activity Measured in Blood
timeFrame: 6 days
measure: Interleukin-6 Measured in Blood
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
Study officials:
affiliation: Western Michigan University
name: Christopher C Cheatham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: