NCT05924139

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. 1.Can performance be improved
  2. 2.Can strength be enhanced
  3. 3.Will positive body composition changes occur (lean vs fat mass)
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

June 5, 2023

Last Update Submit

June 20, 2023

Conditions

Keywords

omega-3 fatty acidstrengthbody compositionmuscle soreness

Outcome Measures

Primary Outcomes (2)

  • Strength

    lower body strength will be evaluated via a counter movement jump

    change from baseline at 8 weeks

  • Power

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

    change from baseline at 8 weeks

Secondary Outcomes (3)

  • Body composition

    change from baseline at 8 weeks

  • Muscle soreness

    change from baseline, every 2 weeks and at 8 weeks

  • Omega-3 index

    change from baseline at 8 weeks

Study Arms (2)

Omega-3 fatty acid

EXPERIMENTAL

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

Coconut oil

PLACEBO COMPARATOR

dose of 4 grams/day

Dietary Supplement: Placebo

Interventions

Omega-3 fatty acidDIETARY_SUPPLEMENT

6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA

Also known as: Nordic Naturals Ultimate Omega
Omega-3 fatty acid
PlaceboDIETARY_SUPPLEMENT

4 capsules per day of coconut oil

Coconut oil

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy college athletes (male and female of all ethnicities) between the ages of 18-25 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • LesLee Funderburk

    Associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 29, 2023

Study Start

March 6, 2023

Primary Completion

May 10, 2023

Study Completion

June 2, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations