The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
Primary Purpose
Muscle Damage, Muscle Inflammation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lovaza (omega-3-acid ethyl esters)
Wheat Germ Oil
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Damage
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
Sites / Locations
- Western Michigan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fish Oil
Control
Arm Description
Lovaza, 3 grams/day for 65 days
Wheat Germ Oil, 3 grams/day for 65 days
Outcomes
Primary Outcome Measures
Quadriceps Muscle Strength
Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.
Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge
The required amount of force applied to the quadriceps to elicit pain or discomfort.
Creatine Kinase Activity Measured in Blood
Creatine kinase activity is an indirect indicator of muscle damage.
Interleukin-6 Measured in Blood
Interleukin-6 is an indirect indicator of muscle inflammation.
Secondary Outcome Measures
Full Information
NCT ID
NCT00805870
First Posted
December 9, 2008
Last Updated
August 1, 2012
Sponsor
Western Michigan University
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00805870
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Michigan University
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Damage, Muscle Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish Oil
Arm Type
Experimental
Arm Description
Lovaza, 3 grams/day for 65 days
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Wheat Germ Oil, 3 grams/day for 65 days
Intervention Type
Drug
Intervention Name(s)
Lovaza (omega-3-acid ethyl esters)
Intervention Description
Lovaza, 3 grams per day for 65 days
Intervention Type
Drug
Intervention Name(s)
Wheat Germ Oil
Intervention Description
Wheat germ oil, 3 grams/day for 65 days
Primary Outcome Measure Information:
Title
Quadriceps Muscle Strength
Description
Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.
Time Frame
6 days
Title
Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge
Description
The required amount of force applied to the quadriceps to elicit pain or discomfort.
Time Frame
6 days
Title
Creatine Kinase Activity Measured in Blood
Description
Creatine kinase activity is an indirect indicator of muscle damage.
Time Frame
6 days
Title
Interleukin-6 Measured in Blood
Description
Interleukin-6 is an indirect indicator of muscle inflammation.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher C Cheatham, Ph.D.
Organizational Affiliation
Western Michigan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Michigan University
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
12. IPD Sharing Statement
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The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
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