Healthy VolunteersNCT07634133
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes
A study testing EPA/DHA supplements and ALA supplements in people with Healthy Volunteers, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
Therefore, the aim of our project will be to assess the impact of omega-3 fatty acid on the neuromuscular system (muscle tensomyography- TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EPA/DHA supplements and ALA 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
- 15 Apr 2025to 31 Dec 2027
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants aged 20-40 years.
- Apparently healthy individuals, as determined by medical history and self-reported health status.
- Physically active, engaging in regular physical activity at least 3 times per week for the previous 6 months.
- Following a mixed diet.
- Willingness to maintain habitual dietary and physical activity patterns throughout the study.
- Willingness to refrain from consuming dietary supplements other than those provided as part of the study.
Who cannot join
- Current use of dietary supplements within 4 weeks prior to enrollment.
- Following a low-carbohydrate, ketogenic, high-carbohydrate, vegetarian, or vegan diet.
- Presence of gastrointestinal disorders affecting nutrient absorption, including irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other clinically significant gastrointestinal conditions.
- History of cardiovascular, metabolic, endocrine, hepatic, renal, neurological, or autoimmune diseases.
- Current use of medications known to affect lipid metabolism, inflammation, antioxidant status, or cognitive function.
- Known allergy or intolerance to study supplements or their ingredients.
- Participation in another clinical trial within the previous 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes
Therefore, the aim of our project will be to assess the impact of omega-3 fatty acid on the neuromuscular system (muscle tensomyography- TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood.
Read the detailed description
The ability of skeletal muscles to generate force and resist fatigue is essential for athletic performance. Training adaptations within the neuromuscular system and skeletal muscles modulate the muscles' ability to produce force and resistance to fatigue. Much research has been conducted to determine the effects of dietary supplements on skeletal muscle adaptation to strength training (e.g., protein supplementation) and methods to support endurance performance (e.g., carbohydrate loading). However, limited research has been conducted to date on the effects of dietary supplements on the neuromuscular system.The research will focus on the effect of 4 and 8 weeks of supplementation with high doses of omega 3 fatty acids on the level of omega 3/omega6 fatty acids, the level of TRANS fatty acids and AA (arachidonic acid) fatty acid using a mixed diet. Additionally, we will examine the effect of this supplementation on the neuromuscular system (muscle tensomyography -TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood. The research will use innovative assumptions - high doses of omega 3 fatty acids. Additionally, a new laboratory tool will be used to assess the level of individual fatty acids (omega 3, omega 6) in the blood, the level of which shows or excludes latent inflammation in the body.
- Conditions
- Healthy Volunteers
- Being tested
- EPA/DHA supplements, ALA supplements, Placebo supplements
- Keywords
- Cognitive function, Omega-3 fatty acids, Alpha-linolenic acid, EPA, DHA, Oxidative stress, Tensiomyography, Body composition, Neuromuscular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPA/DHA supplementsDietary supplement
Also called EPA/DHA supplementation, ALA supplementation, Placebo supplementation
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Each capsule will contain 330mg EPA and 220mgDHA.
ALA supplementsDietary supplement
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg ALA.
Placebo supplementsDietary supplement
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. One capsule will contain 550 mg of olive oil. The placebo will be matched to the supplement in appearance.
| Study group | Role | What they receive |
|---|---|---|
| AL (Alpha-linolenic acid) supplementation | Experimental | Participants were randomly assigned to the ALA supplementation group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the EPA /DHA group. Receives: Dietary Supplement: ALA supplements |
| EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation | Experimental | Participants were randomly assigned to the EPA/DHA supplementation group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the ALA group. Receives: Dietary Supplement: EPA/DHA supplements |
| Placebo supplementation | Placebo comparator | Participants were randomly assigned to the Placebo group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which they repeated the placebo supplementation. Receives: Dietary Supplement: Placebo supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega 3 index
The Omega-3 Index (%) determines the content of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) relative to total fatty acids in erythrocyte membranes. It is expressed as a percentage and reflects long-term fatty acid intake.
Unit of Measure: %
Measured: 4-weeks
Secondary outcomes (4)
Tensiomyography (TMG) Parameters
2a. Maximal Radial Displacement (Dm) Unit of Measure: mm 2b. Contraction Time (Tc) Unit of Measure: ms 2c. Delay Time (Td) Unit of Measure: ms 2d. Sustain Time (Ts) Unit of Measure: ms 2e. Half-Relaxation Time (Tr) Unit of Measure: ms Description: Muscle contractile properties assessed using tensiomyography (TMG-BMC system).
Measured: 4-weeks
Corsi Block-Tapping Test - Unweighted Block Span
Description: Maximum correctly reproduced sequence length in Corsi Block-Tapping Test.
Unit of Measure: blocks
Measured: 4-weeks
Corsi Block-Tapping Test - Block Time
Description: Reaction time performance in visuospatial working memory assessed using Corsi Block-Tapping Test.
Unit of Measure: ms
Measured: 4 weeks
Corsi Block-Tapping Test - Reverse Span Score
Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test.
Unit of Measure: score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start15 Apr 2025
- Primary completion25 Feb 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Crossover
- Model description
- The participants will be randomly assigned to 4 groups: a group supplemented with EPA+DHA (eicosapentaenoic + docosahexaenoic fatty acids) (animal source), a group supplemented with ALA (apha-linolenic) fatty acids (plant source), a placebo supplemented control group, and a control group without supplementation. After 4 weeks of supplementation, there will be a 3 month washout period. After the 3 month break, the second stage will begin, which will also last 4 weeks, during which the groups will be crossed over.
- Masking
- None (open label)
- 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 Magdalena Michalczyk, Phd, Study director, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634133
- Sponsor's protocol ID
- 4-II/2024
- Other IDs
- 2024/53/B/NZ7/02257, RID/SP/0053/2024/01
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes
- ClinicalTrials.gov ID
- NCT07634133
- Acronym / sponsor ID
- 4-II/2024
- Conditions
- Healthy Volunteers
- Keywords
- Cognitive function, Omega-3 fatty acids, Alpha-linolenic acid, EPA, DHA, Oxidative stress, Tensiomyography, Body composition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jun 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.
Therefore, the aim of our project will be to assess the impact of omega-3 fatty acid on the neuromuscular system (muscle tensomyography- TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood.
Detailed description
The ability of skeletal muscles to generate force and resist fatigue is essential for athletic performance. Training adaptations within the neuromuscular system and skeletal muscles modulate the muscles' ability to produce force and resistance to fatigue. Much research has been conducted to determine the effects of dietary supplements on skeletal muscle adaptation to strength training (e.g., protein supplementation) and methods to support endurance performance (e.g., carbohydrate loading). However, limited research has been conducted to date on the effects of dietary supplements on the neuromuscular system.The research will focus on the effect of 4 and 8 weeks of supplementation with high doses of omega 3 fatty acids on the level of omega 3/omega6 fatty acids, the level of TRANS fatty acids and AA (arachidonic acid) fatty acid using a mixed diet. Additionally, we will examine the effect of this supplementation on the neuromuscular system (muscle tensomyography -TMG), the composition and fluidity of erythrocyte cell membranes, the lipid profile and the antioxidant status of the blood. The research will use innovative assumptions - high doses of omega 3 fatty acids. Additionally, a new laboratory tool will be used to assess the level of individual fatty acids (omega 3, omega 6) in the blood, the level of which shows or excludes latent inflammation in the body.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The participants will be randomly assigned to 4 groups: a group supplemented with EPA+DHA (eicosapentaenoic + docosahexaenoic fatty acids) (animal source), a group supplemented with ALA (apha-linolenic) fatty acids (plant source), a placebo supplemented control group, and a control group without supplementation. After 4 weeks of supplementation, there will be a 3 month washout period. After the 3 month break, the second stage will begin, which will also last 4 weeks, during which the groups will be crossed over.
| Arm | Type | Receives |
|---|---|---|
| AL (Alpha-linolenic acid) supplementation | Experimental | Dietary Supplement: ALA supplementsParticipants were randomly assigned to the ALA supplementation group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the EPA /DHA group. |
| EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation | Experimental | Dietary Supplement: EPA/DHA supplementsParticipants were randomly assigned to the EPA/DHA supplementation group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which the participants crossed over to the ALA group. |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo supplementsParticipants were randomly assigned to the Placebo group. After 4 weeks of the supplementation, there was a 12-week wash-out period, after which they repeated the placebo supplementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male participants aged 20-40 years.
- Apparently healthy individuals, as determined by medical history and self-reported health status.
- Physically active, engaging in regular physical activity at least 3 times per week for the previous 6 months.
- Following a mixed diet.
- Willingness to maintain habitual dietary and physical activity patterns throughout the study.
Key exclusion criteria (7 listed)
- Current use of dietary supplements within 4 weeks prior to enrollment.
- Following a low-carbohydrate, ketogenic, high-carbohydrate, vegetarian, or vegan diet.
- Presence of gastrointestinal disorders affecting nutrient absorption, including irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other clinically significant gastrointestinal conditions.
- History of cardiovascular, metabolic, endocrine, hepatic, renal, neurological, or autoimmune diseases.
- Current use of medications known to affect lipid metabolism, inflammation, antioxidant status, or cognitive function.
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 supplementsAlso: EPA/DHA supplementation, ALA supplementation, Placebo supplementationThe supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Each capsule will contain 330mg EPA and 220mgDHA. | Dietary supplement | EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation |
| ALA supplementsThe supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg ALA. | Dietary supplement | AL (Alpha-linolenic acid) supplementation |
| Placebo supplementsThe supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. One capsule will contain 550 mg of olive oil. The placebo will be matched to the supplement in appearance. | Dietary supplement | Placebo supplementation |
Primary outcome
Omega 3 index
Time frame: 4-weeks
The Omega-3 Index (%) determines the content of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) relative to total fatty acids in erythrocyte membranes. It is expressed as a percentage and reflects long-term fatty acid intake. Unit of Measure: %
4 secondary outcomes
Tensiomyography (TMG) Parameters
Time frame: 4-weeks
Corsi Block-Tapping Test - Unweighted Block Span
Time frame: 4-weeks
Corsi Block-Tapping Test - Block Time
Time frame: 4 weeks
Corsi Block-Tapping Test - Reverse Span Score
Time frame: 4 weeks
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. Anonymised data will be available upon reasonable request.
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Screening Protocol
Pain
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 Magdalena Michalczyk, Phd 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 and ALA supplements in people with Healthy Volunteers, 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 8 Jun 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?
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?
Omega 3 index (time frame: 4-weeks). 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 8 Jun 2026.