- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924139
Omega-3 Fatty Acid Supplementation to Enhance Performance (FO n-3)
Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes
The goal of this intervention study is to determine if omega-3 fatty acid supplementation as compared to placebo improves performance in track and field athletes. The main questions it aims to answer are:
- Can performance be improved
- Can strength be enhanced
- Will positive body composition changes occur (lean vs fat mass)
- Will feelings of muscle soreness be diminished Participants will take either omega-3 fatty acid supplements or placebo and continue with their sport specific training regimen.
Researchers will compare the supplement group to placebo group to determine if there are any significant differences.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, placebo-controlled trial to determine the efficacy of fish oil-derived omega-3 fatty acid supplementation. Up to sixty participants will be randomized to receive one of two conditions: 4.0 grams of FO n-3/day or placebo (coconut oil) for the 10-week protocol study period. Nordic Naturals (Ultimate Omega) will be used as the intervention at a dose of 6 capsules/day (3840 mg total FO/1950 mg EPA/1350 mg DHA). Although protocols have varied among studies with regards to dosage, the proposed regimen was selected based on studies on strength in older adults and college-aged athletes utilizing a range of 2-5g FO n-3 per day. Blinded randomization will be accomplished with a research associate providing every first (of two) participants the placebo, while the second will receive the supplemented condition until recruitment is complete. Participants will be provided their supplement in 2-week increments and instructed to consume with/near their evening meal. Used bottles will be returned after two weeks and participants will receive the next 2-week supply of supplement and the leftover pill count will determine compliance rate.
The target population is apparently healthy college athletes (male and female of all ethnicities) between the ages of 18-25 years at Baylor University. Participants must be able to read and understand English and sign their own consent form. Up to 60 subjects will be recruited via direct contact or team briefings with permission of the coaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Waco, Texas, United States, 76798
- Baylor University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Apparently healthy college athletes (male and female of all ethnicities) between the ages of 18-25 years.
Exclusion Criteria: -Participants will be excluded if they are unable to physically train due to injury/illness or are pregnant, or have a known heart condition or pacemaker.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Omega-3 fatty acid
Nordic Naturals (Ultimate Omega) will be used as the intervention at a dose of 4 grams/day (3840 mg total fish oil with 1950 mg EPA and 1350 mg DHA
|
6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA
Other Names:
|
|
Placebo Comparator: Coconut oil
dose of 4 grams/day
|
4 capsules per day of coconut oil
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength
Time Frame: change from baseline at 8 weeks
|
lower body strength will be evaluated via a counter movement jump
|
change from baseline at 8 weeks
|
|
Power
Time Frame: change from baseline at 8 weeks
|
handgrip strength will be used as a proxy for upper body strength via a dynamometer
|
change from baseline at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: change from baseline at 8 weeks
|
bioelectrical impedance analysis (BIA), a double-indirect body composition technique based on a 3-component model (fat mass, fat-free mass, and total body water), will be performed.
|
change from baseline at 8 weeks
|
|
Muscle soreness
Time Frame: change from baseline, every 2 weeks and at 8 weeks
|
Subjects will be asked to rate their muscle soreness on a 10-point Likert scale
|
change from baseline, every 2 weeks and at 8 weeks
|
|
Omega-3 index
Time Frame: change from baseline at 8 weeks
|
The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood
|
change from baseline at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LesLee Funderburk, Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1994931
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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