Omega-3 Fatty Acid Supplementation to Enhance Performance (FO n-3)
Primary Purpose
Strength, Body Composition, Muscle Soreness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acid
Placebo
Sponsored by
About this trial
This is an interventional other trial for Strength focused on measuring omega-3 fatty acid, strength, body composition, muscle soreness
Eligibility Criteria
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.
Sites / Locations
- Baylor University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega-3 fatty acid
Coconut oil
Arm Description
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
dose of 4 grams/day
Outcomes
Primary Outcome Measures
Strength
lower body strength will be evaluated via a counter movement jump
Power
handgrip strength will be used as a proxy for upper body strength via a dynamometer
Secondary Outcome Measures
Body composition
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.
Muscle soreness
Subjects will be asked to rate their muscle soreness on a 10-point Likert scale
Omega-3 index
The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05924139
Brief Title
Omega-3 Fatty Acid Supplementation to Enhance Performance
Acronym
FO n-3
Official Title
Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strength, Body Composition, Muscle Soreness
Keywords
omega-3 fatty acid, strength, body composition, muscle soreness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 fatty acid
Arm Type
Experimental
Arm Description
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
Arm Title
Coconut oil
Arm Type
Placebo Comparator
Arm Description
dose of 4 grams/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acid
Other Intervention Name(s)
Nordic Naturals Ultimate Omega
Intervention Description
6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
4 capsules per day of coconut oil
Primary Outcome Measure Information:
Title
Strength
Description
lower body strength will be evaluated via a counter movement jump
Time Frame
change from baseline at 8 weeks
Title
Power
Description
handgrip strength will be used as a proxy for upper body strength via a dynamometer
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
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.
Time Frame
change from baseline at 8 weeks
Title
Muscle soreness
Description
Subjects will be asked to rate their muscle soreness on a 10-point Likert scale
Time Frame
change from baseline, every 2 weeks and at 8 weeks
Title
Omega-3 index
Description
The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood
Time Frame
change from baseline at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LesLee Funderburk
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Omega-3 Fatty Acid Supplementation to Enhance Performance
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