Muscle Damage, Muscle Inflammation
Conditions
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.
Interventions
DRUGLovaza (omega-3-acid ethyl esters)
Lovaza, 3 grams per day for 65 days
DRUGWheat Germ Oil
Wheat germ oil, 3 grams/day for 65 days
Sponsors
GlaxoSmithKline
Western Michigan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Strength | 6 days | 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 | 6 days | The required amount of force applied to the quadriceps to elicit pain or discomfort. |
| Creatine Kinase Activity Measured in Blood | 6 days | Creatine kinase activity is an indirect indicator of muscle damage. |
| Interleukin-6 Measured in Blood | 6 days | Interleukin-6 is an indirect indicator of muscle inflammation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fish Oil Lovaza, 3 grams/day for 65 days | 10 |
| Control Wheat Germ Oil, 3 grams/day for 65 days | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Fish Oil | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age Continuous | 23.4 years STANDARD_DEVIATION 2.3 | 21.9 years STANDARD_DEVIATION 1.7 | 22.7 years STANDARD_DEVIATION 2.1 |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Creatine Kinase Activity Measured in Blood
Creatine kinase activity is an indirect indicator of muscle damage.
Time frame: 6 days
Population: Number of subjects that completed the protocol. Analysis was per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil | Creatine Kinase Activity Measured in Blood | 110.20 IU/L | Standard Deviation 11.81 |
| Control | Creatine Kinase Activity Measured in Blood | 167.21 IU/L | Standard Deviation 15.18 |
Comparison: Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.p-value: >0.0595% CI: [-156.373, 42.344]ANOVA
Primary
Interleukin-6 Measured in Blood
Interleukin-6 is an indirect indicator of muscle inflammation.
Time frame: 6 days
Population: Number of subjects that completed the protocol. Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil | Interleukin-6 Measured in Blood | 0.23 pg/mL | Standard Deviation 0.07 |
| Control | Interleukin-6 Measured in Blood | 0.21 pg/mL | Standard Deviation 0.05 |
Comparison: The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.p-value: >0.0595% CI: [-0.374, 0.417]ANOVA
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.
Time frame: 6 days
Population: Number of subjects that completed the protocol. Analysis was per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil | Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge | 14.62 lbs | Standard Deviation 0.47 |
| Control | Muscle Soreness of the Quadriceps Using an Algometer Strain Gauge | 16.46 lbs | Standard Deviation 0.37 |
Comparison: Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.p-value: >0.0595% CI: [-4.823, 1.132]ANOVA
Primary
Quadriceps Muscle Strength
Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.
Time frame: 6 days
Population: Number of subjects that completed the protocol. Analysis was per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fish Oil | Quadriceps Muscle Strength | 151 lbs | Standard Deviation 6 |
| Control | Quadriceps Muscle Strength | 160 lbs | Standard Deviation 8 |
Comparison: Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.p-value: >0.0595% CI: [-63.521, 46.978]ANOVA