Muscle DamagePhase 2NCT00805870
The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
A Phase 2 study testing Lovaza (omega-3-acid ethyl esters) and Wheat Germ Oil in people with Muscle Damage and Muscle Inflammation, run by Western Michigan University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Muscle Inflammation
- What is being tested?
- Lovaza (omega-3-acid ethyl esters) and Wheat Germ Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Michigan University
Kalamazoo, Michigan, 49008
About this study
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.
Read the 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.
- Conditions
- Muscle Damage, Muscle Inflammation
- Being tested
- Lovaza (omega-3-acid ethyl esters), Wheat Germ Oil
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza (omega-3-acid ethyl esters)Drug
Lovaza, 3 grams per day for 65 days
Wheat Germ OilDrug
Wheat germ oil, 3 grams/day for 65 days
| Study group | Role | What they receive |
|---|---|---|
| Fish Oil | Experimental | Lovaza, 3 grams/day for 65 days Receives: Drug: Lovaza (omega-3-acid ethyl esters) |
| Control | Placebo comparator | Wheat Germ Oil, 3 grams/day for 65 days Receives: Drug: Wheat Germ Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength
Quadriceps muscle strength is the maximal amount of force that the quadriceps muscles can produce during isometric knee extension exercise.
Measured: 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.
Measured: 6 days
Creatine Kinase Activity Measured in Blood
Creatine kinase activity is an indirect indicator of muscle damage.
Measured: 6 days
Interleukin-6 Measured in Blood
Interleukin-6 is an indirect indicator of muscle inflammation.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Christopher Cheatham, Western Michigan University
- Investigators
- Christopher C Cheatham, Ph.D., Principal investigator, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805870
- Sponsor's protocol ID
- 08-02-31
- Status last verified
- Aug 2012
- First submitted
- 9 Dec 2008
- Last updated
- 5 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT00805870
- Acronym / sponsor ID
- 08-02-31
- Conditions
- Muscle Damage, Muscle Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish Oil | Experimental | Drug: Lovaza (omega-3-acid ethyl esters)Lovaza, 3 grams/day for 65 days |
| Control | Placebo comparator | Drug: Wheat Germ OilWheat Germ Oil, 3 grams/day for 65 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza (omega-3-acid ethyl esters)Lovaza, 3 grams per day for 65 days | Drug | Fish Oil |
| Wheat Germ OilWheat germ oil, 3 grams/day for 65 days | Drug | Control |
Primary outcome
Quadriceps Muscle Strength
Time frame: 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
Time frame: 6 days
The required amount of force applied to the quadriceps to elicit pain or discomfort.
Creatine Kinase Activity Measured in Blood
Time frame: 6 days
Creatine kinase activity is an indirect indicator of muscle damage.
Interleukin-6 Measured in Blood
Time frame: 6 days
Interleukin-6 is an indirect indicator of muscle inflammation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher C Cheatham, Ph.D. principal investigator
Western Michigan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lovaza (omega-3-acid ethyl esters) and Wheat Germ Oil in people with Muscle Damage and Muscle Inflammation, run by Western Michigan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength (time frame: 6 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.