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

NCT07768423 | Recruiting DMC

• 1 other identifier: 4-I/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Performance; Cognitive Function; Sports Nutrition

Keywords

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

Outcome Measures

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.

  From enrollment to the end of 4-week supplementation

Secondary Outcomes (8)

• Neuromuscular function

  From enrollment to the end of supplementation period of 4 weeks

• Hematological parameters and hormones

  From enrollment to the end of supplementation period of 4 weeks

• Lipoprteine profile

  From enrollment to the end of supplementation period of 4 weeks

• Cognitive function

  From enrollment to the end of supplementation period of 4 weeks

• Speed on 5 and 30m

  From enrollment to the end of supplementation period of 4 weeks

Study Arms (2)

Omega-3 fatty acid supplementation group

EXPERIMENTAL

Participants will received 3.5g EPA+ DHA for 4 weeks

Dietary Supplement: EPA + DHA supplements

Placebo group

PLACEBO COMPARATOR

Participants will received 3.5g placebo for 4 weeks

Dietary Supplement: Placebo

Interventions

EPA + DHA supplements DIETARY_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

Omega-3 fatty acid supplementation group

Placebo DIETARY_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.

Placebo group

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead

Study Sites (1)

Jerzy Kukuczka Academy of Physical Education in Katowice

Katowice, Mikolowska 72a, 40-065, Poland

RECRUITING

Study Officials

• Małgorzata M Michalczyk, Proffesor

  Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice

  STUDY DIRECTOR

Central Study Contacts

Małgorzata Magdalena Michalczyk, Professor

CONTACT

+48535016532; m.michalczyk@awf.katowice.pl

Grzegorz Henryk Zydek, assistante profesor

CONTACT

504332664; g.zydek@awf.katowice.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: profesor

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 17, 2026
• Study Start: January 7, 2025
• Primary Completion: February 14, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PL (1)