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

Muscle Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805870
• Other study ID #: 08-02-31
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2008
• Last updated: August 1, 2012
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2012
• Source: Western Michigan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Muscle Damage
• Muscle Inflammation
• Myalgia
• Myositis

Intervention

Drug:
• Lovaza (omega-3-acid ethyl esters)
Lovaza, 3 grams per day for 65 days
• Wheat Germ Oil
Wheat germ oil, 3 grams/day for 65 days

Locations

Country	Name	City	State
United States	Western Michigan University	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Western Michigan University	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Creatine Kinase Activity Measured in Blood	Creatine kinase activity is an indirect indicator of muscle damage.	6 days	No
Primary	Interleukin-6 Measured in Blood	Interleukin-6 is an indirect indicator of muscle inflammation.	6 days	No