MedDataX Logo

The Effects of High Dose Fish Oil Supplementation on Delayed Onset Muscle Soreness and Inflammatory Markers

NCT ID: NCT00805870

Last Updated: 2012-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Damage Muscle Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fish Oil

Lovaza, 3 grams/day for 65 days

Group Type EXPERIMENTAL

Lovaza (omega-3-acid ethyl esters)

Intervention Type DRUG

Lovaza, 3 grams per day for 65 days

Control

Wheat Germ Oil, 3 grams/day for 65 days

Group Type PLACEBO_COMPARATOR

Wheat Germ Oil

Intervention Type DRUG

Wheat germ oil, 3 grams/day for 65 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lovaza (omega-3-acid ethyl esters)

Lovaza, 3 grams per day for 65 days

Intervention Type DRUG

Wheat Germ Oil

Wheat germ oil, 3 grams/day for 65 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Western Michigan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christopher Cheatham

Chair and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christopher C Cheatham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Western Michigan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western Michigan University

Kalamazoo, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-02-31

Identifier Type: -

Identifier Source: org_study_id