- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07634133
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte Membranes
The Impact of Omega-3 Fatty Acid Supplementation on the Composition of Erythrocyte and Neuromuscular System in Athletes
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Katowice, Polen, 40-065
- Academy of Physical Education in Katowice
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
**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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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The supplement will be administered in a dose of 4 capsules twice a day for 4 weeks.
Daily dose will contain 3500mg ALA.
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Eksperimentell: 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.
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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.
Andre navn:
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Placebo komparator: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Omega 3 index
Tidsramme: 4-weeks
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tensiomyography (TMG) Parameters
Tidsramme: 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).
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4-weeks
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Corsi Block-Tapping Test - Unweighted Block Span
Tidsramme: 4-weeks
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Description: Maximum correctly reproduced sequence length in Corsi Block-Tapping Test. Unit of Measure: blocks |
4-weeks
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Corsi Block-Tapping Test - Block Time
Tidsramme: 4 weeks
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Description: Reaction time performance in visuospatial working memory assessed using Corsi Block-Tapping Test. Unit of Measure: ms |
4 weeks
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Corsi Block-Tapping Test - Reverse Span Score
Tidsramme: 4 weeks
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Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test. Unit of Measure: score |
4 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Total Antioxidant Status (TAS)
Tidsramme: 4 weeks
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Description: Plasma total antioxidant status measured using Randox TAS kit. Unit of Measure: mmol/L |
4 weeks
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Malondialdehyde (MDA) Concentration
Tidsramme: 4 weeks
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Description: Plasma malondialdehyde concentration measured using thiobarbituric acid reactive substances method. Unit of Measure: nmol/mL |
4 weeks
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Superoxide Dismutase (SOD) Activity
Tidsramme: 4 weeks
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Description: Activity of superoxide dismutase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
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Glutathione Peroxidase (GPx) Activity
Tidsramme: 4 weeks
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Description: Activity of glutathione peroxidase in red blood cell lysates measured using Randox kits. Unit of Measure: U/g Hb |
4 weeks
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Body Mass
Tidsramme: 4 weeks
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Description: Body mass measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: kg |
4 weeks
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Body Fat Percentage
Tidsramme: 4 weeks
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Description: Body fat percentage measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: % |
4 weeks
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Małgorzata Magdalena Michalczyk, Phd, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 4-II/2024
- 2024/53/B/NZ7/02257 (Annet stipend/finansieringsnummer: Narodowe Centrum Nauki)
- RID/SP/0053/2024/01 (Annen identifikator: The Regional Initiative of Excellence programme)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
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