Clinical trial NCT05924139: Omega-3 Fatty Acid Supplementation to Enhance Performance
Official title: Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength
Body Composition
Muscle Soreness
Keywords: omega-3 fatty acid
strength
body composition
muscle soreness
Lead sponsor: Baylor University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: Strength
timeFrame: change from baseline at 8 weeks
measure: Power
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Body composition
timeFrame: change from baseline at 8 weeks
measure: Muscle soreness
timeFrame: change from baseline, every 2 weeks and at 8 weeks
measure: Omega-3 index
timeFrame: change from baseline at 8 weeks
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Associate professor
name: LesLee Funderburk
role: PRINCIPAL_INVESTIGATOR
References: