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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fish Oil | Experimental | Lovaza, 3 grams/day for 65 days |
|
| Control | Placebo Comparator | Wheat Germ Oil, 3 grams/day for 65 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lovaza (omega-3-acid ethyl esters) | Drug | Lovaza, 3 grams per day for 65 days |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher C Cheatham, Ph.D. | Western Michigan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Michigan University | Kalamazoo | Michigan | 49008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fish Oil | Lovaza, 3 grams/day for 65 days |
| FG001 | Control | Wheat Germ Oil, 3 grams/day for 65 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fish Oil | Lovaza, 3 grams/day for 65 days |
| BG001 | Control | Wheat Germ Oil, 3 grams/day for 65 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quadriceps Muscle Strength | Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise. | Number of subjects that completed the protocol. Analysis was per protocol. | Posted | Mean | Standard Deviation | lbs | 6 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fish Oil | Lovaza, 3 grams/day for 65 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher C. Cheatham | Western Michigan University | 269-387-2542 | chris.cheatham@wmich.edu |
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| ID | Term |
|---|---|
| D018979 | Myositis, Inclusion Body |
| ID | Term |
|---|---|
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| C050055 | wheat germ oil |
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| Wheat Germ Oil |
| Drug |
Wheat germ oil, 3 grams/day for 65 days |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 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. | Number of subjects that completed the protocol. Analysis was per protocol. | Posted | Mean | Standard Deviation | lbs | 6 days |
|
|
|
|
| Primary | Creatine Kinase Activity Measured in Blood | Creatine kinase activity is an indirect indicator of muscle damage. | Number of subjects that completed the protocol. Analysis was per protocol. | Posted | Mean | Standard Deviation | IU/L | 6 days |
|
|
|
|
| Primary | Interleukin-6 Measured in Blood | Interleukin-6 is an indirect indicator of muscle inflammation. | Number of subjects that completed the protocol. Analysis was per protocol | Posted | Mean | Standard Deviation | pg/mL | 6 days |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control | Wheat Germ Oil, 3 grams/day for 65 days | 0 | 10 | 0 | 10 |
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| D009422 |
| Nervous System Diseases |