Physical PerformanceOMEGA-PERFORMNCT07768423
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes in Athletes
A study testing EPA + DHA supplements in people with Physical Performance and Cognitive Function, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
The aim of this study is to evaluate the effects of omega-3 fatty acid supplementation on the Omega-3 Index, erythrocyte membrane composition, cognitive function, hormonal profile, speed, endurance performance, and hematological parameters in competitive athletes aged 16-35 years. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance, Cognitive Function, Sports Nutrition
- What is being tested?
- EPA + DHA supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male competitive soccer players aged 16-35 years.
- Regular participation in organized soccer training and competition.
- A minimum of 6 years of systematic soccer training experience.
- Participation in regular team training during the study period.
- Habitual mixed diet.
- Ability and willingness to maintain usual dietary habits and training load throughout the 4-week intervention.
- Written informed consent provided by the participant.
- For participants under 18 years of age, written informed consent provided by a parent or legal guardian and assent provided by the participant.
Who cannot join
- Current use of omega-3 fatty acid supplements or fish-oil products.
- Use of omega-3 supplements within the 3 months preceding enrollment.
- Known allergy or hypersensitivity to fish, seafood, fish oil, or any ingredient of the study supplements.
- Diagnosed cardiovascular, metabolic, endocrine, gastrointestinal, neurological, inflammatory, autoimmune, or hematological disease.
- Acute infection, injury, or illness that could affect participation in training or study assessments.
- Use of medications or dietary supplements that could influence lipid metabolism, inflammatory status, hormonal profile, blood coagulation, cognitive function, or physical performance.
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- Regular use of anticoagulant or antiplatelet medication.
- Significant change in diet, training volume, or supplementation during the study period.
- Failure to comply with the supplementation protocol or attendance requirements.
- Participation in another clinical or nutritional intervention study during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jerzy Kukuczka Academy of Physical Education in Katowice
Katowice, Mikolowska 72a, 40-065
Małgorzata Michalczyk, Proffesor, 535016532, m.michalczyk@awf.katowice.pl
Grzegorz H Zydek, assistance profesor, 504332664, g.zydek@awf.katowice.pl
About this study
Official title: Effects of Omega-3 Fatty Acid Supplementation on Omega-3 Index, Cognitive Function, Hormonal Profile, Speed, and Endurance in Competitive Athletes Aged 16-35 Years: A Randomized Placebo-Controlled Trial
The aim of this study is to evaluate the effects of omega-3 fatty acid supplementation on the Omega-3 Index, erythrocyte membrane composition, cognitive function, hormonal profile, speed, endurance performance, and hematological parameters in competitive athletes aged 16-35 years.
Read the detailed description
Skeletal muscle function, including the ability to generate force, sustain repeated high-intensity efforts, and resist fatigue, is essential for soccer performance. In addition to neuromuscular adaptations, increasing evidence suggests that nutritional interventions, particularly omega-3 fatty acid supplementation, may influence muscle function, recovery, inflammation, and cognitive performance. However, despite growing interest in omega-3 fatty acids, evidence regarding their effects on physical and cognitive performance in competitive soccer players remains limited.
The present randomized, placebo-controlled trial aims to evaluate the effects of four weeks of high-dose omega-3 fatty acid supplementation in competitive male soccer players aged 16 to 35 years. Participants will continue their regular soccer training and maintain their habitual mixed diet throughout the study.
The primary objective is to determine the effects of supplementation on the Omega-3 Index and the erythrocyte fatty acid profile, including omega-3, omega-6, trans fatty acids, and arachidonic acid (AA). In addition, the study will evaluate changes in cognitive function, hormonal profile, speed and endurance performance, hematological parameters, lipid profile, inflammatory markers, oxidative-antioxidant status, and erythrocyte membrane composition.
The fatty acid profile will be assessed using a validated laboratory method that enables quantitative determination of individual fatty acids in erythrocyte membranes, providing an objective biomarker of long-term omega-3 status and membrane lipid composition. This approach allows comprehensive evaluation of the biological response to omega-3 supplementation in competitive athletes.
The findings of this study are expected to improve understanding of the physiological effects of high-dose omega-3 fatty acid supplementation in soccer players and may contribute to evidence-based nutritional strategies aimed at optimizing health, recovery, cognitive function, and athletic performance.
- Conditions
- Physical Performance, Cognitive Function, Sports Nutrition
- Being tested
- EPA + DHA supplements, Placebo
- Keywords
- Omega-3 fatty acids, Physical performance, Randomized controlled trial, Erythrocyte membrane fatty acids, Sports nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA + DHA supplementsDietary supplement
Participants will randomly assigned to the supplemented group. The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg EPA + DHA
PlaceboDietary supplement
Participants will randomly assigned to the Placebo group. The placebo will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg MCT.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 fatty acid supplementation group | Experimental | Participants will received 3.5g EPA+ DHA for 4 weeks Receives: Dietary Supplement: EPA + DHA supplements |
| Placebo group | Placebo comparator | Participants will received 3.5g placebo for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Omega Index
The Omega-3 Index will be assessed in erythrocytes as the combined percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to total fatty acids in erythrocyte membranes. Blood samples will be collected at baseline and after the 4-week supplementation period. In addition to the Omega-3 Index, the erythrocyte fatty acid profile, including individual omega-3 and omega-6 fatty acids, arachidonic acid (AA), and trans fatty acids, will be assessed. Changes from baseline to the end of the 4-week intervention will be evaluated.
Measured: From enrollment to the end of 4-week supplementation
Secondary outcomes (8)
Neuromuscular function
Neuromuscular function was assessed using tensiomyography (TMG), a non-invasive method for evaluating the contractile properties of skeletal muscles. Parameters including contraction time (Tc), delay time (Td), sustain time (Ts), relaxation time (Tr), and maximal radial displacement (Dm) were measured at baseline and after the 4-week intervention.
Measured: From enrollment to the end of supplementation period of 4 weeks
Hematological parameters and hormones
Hematological parameters were assessed using fasting venous blood samples. Outcome measures included complete blood count variables, including red blood cell count, white blood cell count, hemoglobin, hematocrit, platelet count, and red blood cell indices. Also testosteron and cortisol concentration was measured. Changes from baseline to the end of the 4-week intervention were evaluated.
Measured: From enrollment to the end of supplementation period of 4 weeks
Lipoprteine profile
The lipoprotein profile was assessed using fasting blood samples. Outcome measures included total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides. Changes from baseline to the end of the 4-week intervention were evaluated.
Measured: From enrollment to the end of supplementation period of 4 weeks
Cognitive function
Cognitive function was assessed using the Corsi Block-Tapping Test, which evaluates visuospatial working memory, short-term memory capacity, and executive cognitive performance. Changes in test performance were compared between baseline and the end of the 4-week intervention.
Measured: From enrollment to the end of supplementation period of 4 weeks
Speed on 5 and 30m
Running times will be recorded using two pairs of dual-beam Witty Gate photocells (Microgate, Bolzano, Italy), a valid and reliable system for sprint performance assessment. Following a standardized warm-up, participants will perform two maximal 30-m sprint trials on an indoor artificial grass surface, with 15 minutes of passive recovery between trials. To prevent premature activation of the timing system, participants will start with the leading foot positioned 0.5 m behind the first timing gate. Split times at 5 m and 30 m will be recorded automatically, and the best performance from the two trials will be used for statistical analysis.
Measured: From enrollment to the end of supplementation period of 4 weeks
Anaerobic performance
Anaerobic performance will be assessed using the Running-Based Anaerobic Sprint Test (RAST). Following a standardized warm-up, participants will perform six maximal 35-m sprints separated by 10 seconds of passive recovery. Sprint times will be recorded using an electronic timing system. Peak power, mean power, minimum power, fatigue index, and total sprint time will be calculated according to the standard RAST protocol. All tests will be performed under standardized environmental conditions, and participants will receive standardized verbal encouragement throughout the test.
Measured: From enrollment to the end of supplementation period of 4 weeks
CMJ performance
Countermovement jump performance will be assessed using dual force plates (ForceDecks, VALD Performance, Australia), a validated system for quantifying vertical jump kinetics and kinematics. Before testing, participants will stand quietly on the force plates for 3 seconds to determine body mass and baseline force.
The testing protocol will include bilateral countermovement jumps with arm swing (CMJa) and unilateral countermovement jumps performed separately on the dominant and non-dominant limbs. Participants will perform a rapid countermovement followed immediately by a maximal vertical jump. Three maximal trials will be completed for each test, with 1 minute of passive recovery between bilateral trials and 30 seconds between unilateral trials. The best trial for each test will be retained for analysis.
Vertical ground reaction force data will be sampled at 1000 Hz and analyzed using the manufacturer's software. Outcome measures will incl
Measured: From enrollment to the end of 4-week supplementation
Change in Reactive Strength and Leg Stiffness
Reactive strength and lower-limb stiffness will be assessed using the Myotest Pro system during three consecutive maximal plyometric jumps. Outcome measures will include reactive strength index (RSI) and leg stiffness. Changes from baseline to the end of the 4-week intervention will be evaluated.
Measured: From enrollment to the end of 4-week supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start7 Jan 2025
- Primary completion14 Feb 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the omega-3 supplementation group or the placebo group. Both groups were followed in parallel throughout the 4-week intervention period while maintaining their regular training program and habitual diet.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Małgorzata Magdalena Michalczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Małgorzata M Michalczyk, Proffesor, Study director, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768423
- Sponsor's protocol ID
- 4-I/2024
- Other IDs
- 4-I/2024
- Acronym
- OMEGA-PERFORM
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 Fatty Acid Supplementation on Omega-3 Index, Cognitive Function, Hormonal Profile, Speed, and Endurance in Competitive Athletes Aged 16-35 Years: A Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07768423
- Acronym / sponsor ID
- OMEGA-PERFORM / 4-I/2024
- Conditions
- Physical Performance, Cognitive Function, Sports Nutrition
- Keywords
- Omega-3 fatty acids, Physical performance, Randomized controlled trial, Erythrocyte membrane fatty acids, Sports nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (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 aim of this study is to evaluate the effects of omega-3 fatty acid supplementation on the Omega-3 Index, erythrocyte membrane composition, cognitive function, hormonal profile, speed, endurance performance, and hematological parameters in competitive athletes aged 16-35 years.
Detailed description
Skeletal muscle function, including the ability to generate force, sustain repeated high-intensity efforts, and resist fatigue, is essential for soccer performance. In addition to neuromuscular adaptations, increasing evidence suggests that nutritional interventions, particularly omega-3 fatty acid supplementation, may influence muscle function, recovery, inflammation, and cognitive performance. However, despite growing interest in omega-3 fatty acids, evidence regarding their effects on physical and cognitive performance in competitive soccer players remains limited.
The present randomized, placebo-controlled trial aims to evaluate the effects of four weeks of high-dose omega-3 fatty acid supplementation in competitive male soccer players aged 16 to 35 years. Participants will continue their regular soccer training and maintain their habitual mixed diet throughout the study.
The primary objective is to determine the effects of supplementation on the Omega-3 Index and the erythrocyte fatty acid profile, including omega-3, omega-6, trans fatty acids, and arachidonic acid (AA). In addition, the study will evaluate changes in cognitive function, hormonal profile, speed and endurance performance, hematological parameters, lipid profile, inflammatory markers, oxidative-antioxidant status, and erythrocyte membrane composition.
The fatty acid profile will be assessed using a validated laboratory method that enables quantitative determination of individual fatty acids in erythrocyte membranes, providing an objective biomarker of long-term omega-3 status and membrane lipid composition. This approach allows comprehensive evaluation of the biological response to omega-3 supplementation in competitive athletes.
The findings of this study are expected to improve understanding of the physiological effects of high-dose omega-3 fatty acid supplementation in soccer players and may contribute to evidence-based nutritional strategies aimed at optimizing health, recovery, cognitive function, and athletic performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the omega-3 supplementation group or the placebo group. Both groups were followed in parallel throughout the 4-week intervention period while maintaining their regular training program and habitual diet.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acid supplementation group | Experimental | Dietary Supplement: EPA + DHA supplementsParticipants will received 3.5g EPA+ DHA for 4 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants will received 3.5g placebo for 4 weeks |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male competitive soccer players aged 16-35 years.
- Regular participation in organized soccer training and competition.
- A minimum of 6 years of systematic soccer training experience.
- Participation in regular team training during the study period.
- Habitual mixed diet.
Key exclusion criteria (10 listed)
- Current use of omega-3 fatty acid supplements or fish-oil products.
- Use of omega-3 supplements within the 3 months preceding enrollment.
- Known allergy or hypersensitivity to fish, seafood, fish oil, or any ingredient of the study supplements.
- Diagnosed cardiovascular, metabolic, endocrine, gastrointestinal, neurological, inflammatory, autoimmune, or hematological disease.
- Acute infection, injury, or illness that could affect participation in training or study assessments.
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 |
|---|---|---|
| EPA + DHA supplementsParticipants will randomly assigned to the supplemented group. The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg EPA + DHA | Dietary supplement | Omega-3 fatty acid supplementation group |
| PlaceboParticipants will randomly assigned to the Placebo group. The placebo will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg MCT. | Dietary supplement | Placebo group |
Primary outcome
Change in Omega Index
Time frame: From enrollment to the end of 4-week supplementation
The Omega-3 Index will be assessed in erythrocytes as the combined percentage of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to total fatty acids in erythrocyte membranes. Blood samples will be collected at baseline and after the 4-week supplementation period. In addition to the Omega-3 Index, the erythrocyte fatty acid profile, including individual omega-3 and omega-6 fatty acids, arachidonic acid (AA), and trans fatty acids, will be assessed. Changes from baseline to the end of the 4-week intervention will be evaluated.
8 secondary outcomes
Neuromuscular function
Time frame: From enrollment to the end of supplementation period of 4 weeks
Hematological parameters and hormones
Time frame: From enrollment to the end of supplementation period of 4 weeks
Lipoprteine profile
Time frame: From enrollment to the end of supplementation period of 4 weeks
Cognitive function
Time frame: From enrollment to the end of supplementation period of 4 weeks
Speed on 5 and 30m
Time frame: From enrollment to the end of supplementation period of 4 weeks
Anaerobic performance
Time frame: From enrollment to the end of supplementation period of 4 weeks
CMJ performance
Time frame: From enrollment to the end of 4-week supplementation
Change in Reactive Strength and Leg Stiffness
Time frame: From enrollment to the end of 4-week supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Anonymised data will be available upon reasonable request.
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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.
Małgorzata M Michalczyk, Proffesor study director
Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPA + DHA supplements in people with Physical Performance and Cognitive Function, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Małgorzata Magdalena Michalczyk, Professor (+48535016532, m.michalczyk@awf.katowice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Omega Index (time frame: From enrollment to the end of 4-week supplementation). 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 17 Aug 2026.