The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2008
CompletedFirst Posted
Study publicly available on registry
December 10, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
September 5, 2012
CompletedSeptember 5, 2012
August 1, 2012
9 months
December 9, 2008
August 11, 2011
August 1, 2012
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Fish Oil
EXPERIMENTALLovaza, 3 grams/day for 65 days
Control
PLACEBO COMPARATORWheat Germ Oil, 3 grams/day for 65 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western Michigan Universitylead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Western Michigan University
Kalamazoo, Michigan, 49008, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Christopher C. Cheatham
- Organization
- Western Michigan University
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher C Cheatham, Ph.D.
Western Michigan University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair and Associate Professor
Study Record Dates
First Submitted
December 9, 2008
First Posted
December 10, 2008
Study Start
March 1, 2009
Primary Completion
December 1, 2009
Study Completion
February 1, 2010
Last Updated
September 5, 2012
Results First Posted
September 5, 2012
Record last verified: 2012-08