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

NCT07634133 | Enrolling By Invitation DMC

• 3 other identifiers: 4-II/20242024/53/B/NZ7/02257RID/SP/0053/2024/01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Cognitive function; Omega-3 fatty acids; Alpha-linolenic acid; EPA; DHA; Oxidative stress; Tensiomyography; Body composition; Neuromuscular function

Outcome Measures

Primary Outcomes (1)

• 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: %

  4-weeks

Secondary Outcomes (4)

• Tensiomyography (TMG) Parameters

  4-weeks

• Corsi Block-Tapping Test - Unweighted Block Span

  4-weeks

• Corsi Block-Tapping Test - Block Time

  4 weeks

• Corsi Block-Tapping Test - Reverse Span Score

  4 weeks

Other Outcomes (6)

• Total Antioxidant Status (TAS)

  4 weeks

• Malondialdehyde (MDA) Concentration

  4 weeks

• Superoxide Dismutase (SOD) Activity

  4 weeks

Study Arms (3)

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.

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.

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.

Dietary Supplement: Placebo supplements

Interventions

EPA/DHA supplements DIETARY_SUPPLEMENT

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.

Also known as: EPA/DHA supplementation, ALA supplementation, Placebo supplementation

EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation

ALA supplements DIETARY_SUPPLEMENT

The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks. Daily dose will contain 3500mg ALA.

AL (Alpha-linolenic acid) supplementation

Placebo supplements DIETARY_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.

Placebo supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Academy of Physical Education in Katowice

Katowice, 40-065, Poland

Location

Study Officials

• Małgorzata Magdalena Michalczyk, Phd

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 8, 2026
• Study Start: April 15, 2025
• Primary Completion: February 25, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

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

Locations

PL (1)