- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Katowice, Pologne, 40-065
- Academy of Physical Education in Katowice
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
**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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur placebo: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Omega 3 index
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tensiomyography (TMG) Parameters
Délai: 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
Délai: 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
Délai: 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
Délai: 4 weeks
|
Description: Working memory performance assessed using reverse span condition of Corsi Block-Tapping Test. Unit of Measure: score |
4 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total Antioxidant Status (TAS)
Délai: 4 weeks
|
Description: Plasma total antioxidant status measured using Randox TAS kit. Unit of Measure: mmol/L |
4 weeks
|
|
Malondialdehyde (MDA) Concentration
Délai: 4 weeks
|
Description: Plasma malondialdehyde concentration measured using thiobarbituric acid reactive substances method. Unit of Measure: nmol/mL |
4 weeks
|
|
Superoxide Dismutase (SOD) Activity
Délai: 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
Délai: 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
Délai: 4 weeks
|
Description: Body mass measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: kg |
4 weeks
|
|
Body Fat Percentage
Délai: 4 weeks
|
Description: Body fat percentage measured using multi-frequency bioelectrical impedance analysis (InBody 770). Unit of Measure: % |
4 weeks
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Małgorzata Magdalena Michalczyk, Phd, Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 4-II/2024
- 2024/53/B/NZ7/02257 (Autre subvention/numéro de financement: Narodowe Centrum Nauki)
- RID/SP/0053/2024/01 (Autre identifiant: The Regional Initiative of Excellence programme)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .