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FO n-3: Omega-3 Fatty Acid Supplementation to Enhance Performance

Sponsor
Baylor University (Other)
Overall Status
Completed
CT.gov ID
NCT05924139
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
2.9
Actual Duration (Months)
11.4
Patients Per Site Per Month

Study Details

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:

  1. Can performance be improved

  2. Can strength be enhanced

  3. Will positive body composition changes occur (lean vs fat mass)

  4. 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Omega-3 fatty acid
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes
Actual Study Start Date :
Mar 6, 2023
Actual Primary Completion Date :
May 10, 2023
Actual Study Completion Date :
Jun 2, 2023

Arms and Interventions

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

Dietary Supplement: Omega-3 fatty acid
6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA
Other Names:
  • Nordic Naturals Ultimate Omega

    		•
    Placebo Comparator: Coconut oil

    dose of 4 grams/day

    Dietary Supplement: Placebo
    4 capsules per day of coconut oil

    Outcome Measures

    Primary Outcome Measures

    1. Strength [change from baseline at 8 weeks]

      lower body strength will be evaluated via a counter movement jump

    2. Power [change from baseline at 8 weeks]

      handgrip strength will be used as a proxy for upper body strength via a dynamometer

    Secondary Outcome Measures

    1. Body composition [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.

    2. Muscle soreness [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

    3. Omega-3 index [change from baseline at 8 weeks]

      The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor University Waco Texas United States 76798

    Sponsors and Collaborators

    • Baylor University

    Investigators

    • Principal Investigator: LesLee Funderburk, Associate professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baylor University
    ClinicalTrials.gov Identifier:
    NCT05924139
    Other Study ID Numbers:
    • 1994931
    First Posted:
    Jun 29, 2023
    Last Update Posted:
    Jun 29, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Baylor University
    omega-3 fatty acid
    strength
    body composition
    muscle soreness
    Additional relevant MeSH terms:
    Myalgia

    Study Results

    No Results Posted as of Jun 29, 2023