StrengthFO n-3NCT05924139
Omega-3 Fatty Acid Supplementation to Enhance Performance
A study testing Omega-3 fatty acid in people with Strength and Body Composition, run by Baylor University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Strength, Body Composition, Muscle Soreness
- What is being tested?
- Omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 2 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Strength, Body Composition, Muscle Soreness
- Being tested
- Omega-3 fatty acid, Placebo
- Keywords
- omega-3 fatty acid, strength, body composition, muscle soreness
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidDietary supplement
Also called Nordic Naturals Ultimate Omega
6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA
PlaceboDietary supplement
4 capsules per day of coconut oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Omega-3 fatty acid |
| Coconut oil | Placebo comparator | dose of 4 grams/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
lower body strength will be evaluated via a counter movement jump
Measured: change from baseline at 8 weeks
Power
handgrip strength will be used as a proxy for upper body strength via a dynamometer
Measured: change from baseline at 8 weeks
Secondary outcomes (3)
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.
Measured: change from baseline at 8 weeks
Muscle soreness
Subjects will be asked to rate their muscle soreness on a 10-point Likert scale
Measured: change from baseline, every 2 weeks and at 8 weeks
Omega-3 index
The Omega-3 Index provides information on the participants baseline level of EPA/DHA level in the blood
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Mar 2023
- Primary completion10 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LesLee Funderburk, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924139
- Sponsor's protocol ID
- 1994931
- Acronym
- FO n-3
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Supplementation to Enhance Performance in Collegiate Athletes
- ClinicalTrials.gov ID
- NCT05924139
- Acronym / sponsor ID
- FO n-3 / 1994931
- Conditions
- Strength, Body Composition, Muscle Soreness
- Keywords
- omega-3 fatty acid, strength, body composition, muscle soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid | Experimental | Dietary Supplement: Omega-3 fatty acidNordic 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 |
| Coconut oil | Placebo comparator | Dietary Supplement: Placebodose of 4 grams/day |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidAlso: Nordic Naturals Ultimate Omega6 capsules per day of 3840 mg that included 1950 mg EPA and 1350 mg DHA | Dietary supplement | Omega-3 fatty acid |
| Placebo4 capsules per day of coconut oil | Dietary supplement | Coconut oil |
Primary outcome
Strength
Time frame: change from baseline at 8 weeks
lower body strength will be evaluated via a counter movement jump
Power
Time frame: change from baseline at 8 weeks
handgrip strength will be used as a proxy for upper body strength via a dynamometer
3 secondary outcomes
Body composition
Time frame: change from baseline at 8 weeks
Muscle soreness
Time frame: change from baseline, every 2 weeks and at 8 weeks
Omega-3 index
Time frame: change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LesLee Funderburk principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 fatty acid in people with Strength and Body Composition, run by Baylor University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: change from baseline at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.