ClinicalTrials.gg
RecruitingNCT07768423OMEGA-PERFORMUpdated Aug 17, 2026

The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes in Athletes

An interventional study of EPA + DHA supplements and Placebo in Physical Performance, Cognitive Function and Sports Nutrition, sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice. Recruiting at 1 site in Poland. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2025, registered Aug 2026).
  • Started Jan 2025; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
16 Years to 35 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Physical Performance
  • Cognitive Function
  • Sports Nutrition

Keywords

  • Omega-3 fatty acids
  • Physical performance
  • Randomized controlled trial
  • Erythrocyte membrane fatty acids
  • Sports nutrition
03

In context

Lead sponsor

The Jerzy Kukuczka Academy of Physical Education in Katowice is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

**Inclusion Criteria:**

  • 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 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.

**Exclusion Criteria:**

  • 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 to fish, seafood, fish oil, or any ingredient of the study supplements.
  • Diagnosed cardiovascular, metabolic, endocrine, gastrointestinal, neurological, inflammatory, , 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.
  • 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Omega-3 fatty acid supplementation group

    Participants will received 3.5g EPA+ DHA for 4 weeks

    Dietary Supplement: EPA + DHA supplements

  • Placebo comparator
    Placebo group

    Participants will received 3.5g placebo for 4 weeks

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementEPA + DHA supplements

    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

  • Dietary supplementPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of 4-week supplementation

Secondary outcomes

  1. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  2. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  3. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  4. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  5. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  6. 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.

    Time frame: From enrollment to the end of supplementation period of 4 weeks

  7. 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

    Time frame: From enrollment to the end of 4-week supplementation

  8. 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.

    Time frame: From enrollment to the end of 4-week supplementation

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Anonymised data will be available upon reasonable request.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07768423
Lead sponsor
The Jerzy Kukuczka Academy of Physical Education in Katowice
Responsible party
Małgorzata Magdalena Michalczyk (profesor, The Jerzy Kukuczka Academy of Physical Education in Katowice) — Principal investigator
First posted
Aug 17, 2026
Start date
Jan 7, 2025
Primary completion
Feb 14, 2025
Completion
Dec 31, 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Małgorzata Magdalena Michalczyk, Professor
Contact
m.michalczyk@awf.katowice.pl
+48535016532
Grzegorz Henryk Zydek, assistante profesor
Contact
g.zydek@awf.katowice.pl
504332664
Małgorzata M Michalczyk, Proffesor
study director · Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion