The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes
3 de junio de 2026 actualizado por: Małgorzata Magdalena Michalczyk, The Jerzy Kukuczka Academy of Physical Education in Katowice
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.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Katowice, Polonia, 40-065
- Academy of Physical Education in Katowice
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
**Inclusion Criteria:**
- 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.
**Exclusion Criteria:**
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: AL (Alpha-linolenic acid) supplementation
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.
|
The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Daily dose will contain 3500mg ALA.
|
|
Experimental: EPA (eicosapentaenoic acid)/DHA (docosahexaenoic acid) supplementation
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.
|
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.
Otros nombres:
|
|
Comparador de placebos: Placebo supplementation
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Omega 3 index
Periodo de tiempo: 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-weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tensiomyography (TMG) Parameters
Periodo de tiempo: 4-weeks
|
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).
|
4-weeks
|
|
Corsi Block-Tapping Test - Unweighted Block Span
Periodo de tiempo: 4-weeks
|
Description: Maximum correctly reproduced sequence length in Corsi Block-Tapping Test. Unit of Measure: blocks |
4-weeks
|
|
Corsi Block-Tapping Test - Block Time
Periodo de tiempo: 4 weeks
|
Description: Reaction time performance in visuospatial working memory assessed using Corsi Block-Tapping Test. Unit of Measure: ms |
4 weeks
|
|
Corsi Block-Tapping Test - Reverse Span Score
Periodo de tiempo: 4 weeks
|
Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test. Unit of Measure: score |
4 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Total Antioxidant Status (TAS)
Periodo de tiempo: 4 weeks
|
Description: Plasma total antioxidant status measured using Randox TAS kit. Unit of Measure: mmol/L |
4 weeks
|
|
Malondialdehyde (MDA) Concentration
Periodo de tiempo: 4 weeks
|
Description: Plasma malondialdehyde concentration measured using thiobarbituric acid reactive substances method. Unit of Measure: nmol/mL |
4 weeks
|
|
Superoxide Dismutase (SOD) Activity
Periodo de tiempo: 4 weeks
|
Description: Activity of superoxide dismutase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
|
Glutathione Peroxidase (GPx) Activity
Periodo de tiempo: 4 weeks
|
Description: Activity of glutathione peroxidase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
|
|
Body Mass
Periodo de tiempo: 4 weeks
|
Description: Body mass measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: kg |
4 weeks
|
|
Body Fat Percentage
Periodo de tiempo: 4 weeks
|
Description: Body fat percentage measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: % |
4 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Director de estudio: Małgorzata Magdalena Michalczyk, Phd, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de abril de 2025
Finalización primaria (Actual)
25 de febrero de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 4-II/2024
- 2024/53/B/NZ7/02257 (Otro número de subvención/financiamiento: Narodowe Centrum Nauki)
- RID/SP/0053/2024/01 (Otro identificador: The Regional Initiative of Excellence programme)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Anonymised data will be available upon reasonable request.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .