- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07696052
Phosphatidylserine, Taurine, and Caffeine for Cognitive Fatigue in Professional Football Players (TCPS-Foot)
9 septembre 2026 mis à jour par: Krzysztof Mizera, Vizja University in Warsaw
Neurocognitive Fatigue Resistance, Visual Search Efficiency, and Tactical Decision-Making After Phosphatidylserine-Containing Taurine-Caffeine Supplementation in Professional Male Football Players
This randomized, double-blind, placebo-controlled, parallel-group trial evaluated neurocognitive fatigue resistance and football-specific decision-making following 28 days of taurine-caffeine supplementation with or without phosphatidylserine in professional male football players.
Sixty-five male outfield football players from two professional clubs were randomized to placebo, taurine plus caffeine, or taurine plus caffeine plus phosphatidylserine.
Neurocognitive fatigue resistance was evaluated during a standardized high-load Stroop/Flanker task, while football-specific tactical decision-making, visual-search behavior, and field-based reactive decision performance were assessed at baseline and after 28 days of supplementation.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This study was designed to determine whether adding phosphatidylserine to taurine-caffeine supplementation improves neurocognitive fatigue resistance and football-specific decision-making in professional male football players.
Participants completed familiarization procedures, baseline laboratory and field testing, 28 days of supplementation, and post-intervention laboratory and field testing.
Neurocognitive fatigue resistance was assessed using a standardized high-load Stroop/Flanker protocol.
Football-specific decision-making was evaluated using video-based tactical decision tasks incorporating offensive and transitional match situations and requiring rapid selection of the most appropriate tactical response.
Visual-search behavior was assessed using screen-based eye tracking during the football-specific decision task.
Field-based reactive decision performance was evaluated using a standardized Reactive Passing Decision Test requiring perception of an external visual stimulus followed by selection and execution of the appropriate passing response.
Outcome assessments were conducted before and after the 28-day supplementation period under standardized testing conditions.
Type d'étude
Interventionnel
Inscription (Réel)
65
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Lodz, Pologne
- Professional Football Training Center
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Warsaw, Pologne
- Professional Football Training Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Male professional outfield football players aged 18 to 37 years.
- First-team players or selected U19 players aged 18 years or older who are regularly integrated into first-team training.
- Regular participation in club training.
- At least 5 years of systematic football training experience.
- Free from injury or illness limiting full participation in training and testing.
- Normal or corrected-to-normal vision.
- Ability to complete the laboratory and field-based testing procedures.
- Written informed consent provided before participation.
Exclusion Criteria:
- Goalkeepers.
- Current injury or illness limiting full participation in testing.
- Neurological disease.
- Recent concussion or head trauma.
- Uncorrected visual impairment.
- Use of phosphatidylserine, nootropic agents, or strong stimulants during the previous 4 weeks.
- Non-standard caffeine intake on testing days.
- Failure to comply with pre-test standardization procedures.
- Failed eye-tracker calibration.
- Loss of more than 30% of gaze data during the football-specific decision-making task.
- Withdrawal of consent.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
Participants randomized to this arm will receive an inert placebo for 28 days.
The placebo will be provided in identical coded packs matched for appearance, number of units, and packaging with the active supplements.
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Inert placebo matched with the active supplements for appearance, number of units, and packaging.
The placebo will be administered for 28 days.
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Comparateur actif: Taurine Plus Caffeine
Participants randomized to this arm will receive taurine 1500 mg/day plus caffeine 200 mg/day for 28 days.
On training and testing days, the supplement will be consumed approximately 60 minutes before the main training session or testing procedure.
On non-training days, it will be consumed at a consistent morning time.
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Taurine 1500 mg/day plus caffeine 200 mg/day administered for 28 days.
On training and testing days, the supplement will be consumed approximately 60 minutes before the main training session or testing procedure.
On non-training days, it will be consumed at a consistent morning time.
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Expérimental: Taurine, Caffeine, and Phosphatidylserine
Participants randomized to this arm will receive taurine 1500 mg/day plus caffeine 200 mg/day plus phosphatidylserine 600 mg/day for 28 days.
On training and testing days, the supplement will be consumed approximately 60 minutes before the main training session or testing procedure.
On non-training days, it will be consumed at a consistent morning time.
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Taurine 1500 mg/day plus caffeine 200 mg/day plus phosphatidylserine 600 mg/day administered for 28 days.
On training and testing days, the supplement will be consumed approximately 60 minutes before the main training session or testing procedure.
On non-training days, it will be consumed at a consistent morning time.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tactical Inhibitory Decision Accuracy Under Neurocognitive Load
Délai: Baseline and 28 days of supplementation
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Tactical inhibitory decision accuracy will be assessed using football-specific video clips requiring inhibition of an immediately attractive but suboptimal tactical action.
Responses will be scored as 1 point for an optimal decision, 0.5 points for an acceptable decision, and 0 points for an incorrect decision.
The outcome will be calculated as the mean score across inhibitory tactical clips.
The score ranges from 0 to 1, with higher values indicating better tactical inhibitory decision accuracy.
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Baseline and 28 days of supplementation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall Football-Specific Optimal Decision Rate
Délai: Baseline and 28 days of supplementation
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Overall football-specific decision accuracy will be assessed using video-based offensive and transitional football situations.
Players will select the most appropriate tactical option under time pressure.
The outcome will be expressed as the percentage of correct or expert-rated optimal decisions, with higher values indicating better decision-making accuracy.
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Baseline and 28 days of supplementation
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Football-Specific Decision Time
Délai: Baseline and 28 days of supplementation
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Decision time will be assessed during the football-specific video decision-making task.
It will be measured as the time taken to select a tactical response after the critical decision point.
The outcome will be expressed in milliseconds, with lower values indicating faster decision-making.
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Baseline and 28 days of supplementation
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Impulsive Tactical Error Rate
Délai: Baseline and 28 days of supplementation
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Impulsive tactical errors will be assessed during football-specific video clips.
These errors will include selections of immediately attractive but suboptimal tactical options, such as inappropriate forward actions, low-quality shots, or forced progressive decisions when a safer or more appropriate option is available.
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Baseline and 28 days of supplementation
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Stroop/Flanker Time-on-Task Reaction-Time Trajectory
Délai: Baseline and 28 days of supplementation
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Correct-trial reaction time will be assessed across six consecutive 5-minute epochs of the 30-minute high-load Stroop/Flanker task.
Time-on-task performance decrement will be quantified from the within-session trajectory of reaction time across successive epochs, with a greater increase in reaction time indicating greater neurocognitive performance deterioration and a smaller increase indicating greater neurocognitive fatigue resistance.
Response accuracy across epochs will be reported as a complementary measure.
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Baseline and 28 days of supplementation
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Stroop/Flanker Reaction-Time Variability
Délai: Baseline and 28 days of supplementation
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Reaction-time variability will be assessed during the 30-minute high-load Stroop/Flanker task.
It will be quantified from valid correct-trial reaction times as a within-participant measure of response-time variability and expressed in milliseconds, with greater variability indicating lower response stability.
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Baseline and 28 days of supplementation
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Post-Task Mental Fatigue
Délai: Baseline and 28 days of supplementation
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Perceived mental fatigue will be assessed immediately before and immediately after the 30-minute neurocognitive-load task using a 0-10 numerical rating scale, with higher scores indicating greater perceived mental fatigue.
The registered outcome will be the post-task mental-fatigue score assessed at baseline and after 28 days of supplementation.
The acute pre-to-post task change will additionally be used as a manipulation check of the neurocognitive-load protocol.
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Baseline and 28 days of supplementation
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Time to First Fixation on the Optimal Tactical Area of Interest
Délai: Baseline and 28 days of supplementation
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Time to first fixation on the optimal tactical option will be assessed using screen-based eye-tracking during the football-specific video decision-making task.
The outcome will be expressed in milliseconds and will reflect how quickly the player visually orients toward the expert-defined optimal option.
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Baseline and 28 days of supplementation
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Dwell Time on the Optimal Tactical Area of Interest
Délai: Baseline and 28 days of supplementation
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Dwell time on the optimal tactical option will be assessed using screen-based eye-tracking during the football-specific video decision-making task.
The outcome will be expressed as the percentage of total viewing time spent fixating on the expert-defined optimal tactical option.
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Baseline and 28 days of supplementation
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Situational-Awareness Accuracy
Délai: Baseline and 28 days of supplementation
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Situational awareness accuracy will be assessed using probes presented after selected football-specific video clips.
These probes will evaluate whether players correctly identified key tactical information, including available space, pressure location, number of defenders, teammate positioning, and defensive-line configuration.
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Baseline and 28 days of supplementation
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Reactive Passing Decision-Selection Accuracy
Délai: Baseline and 28 days of supplementation
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Reactive Passing Decision Test accuracy will be assessed during a field-based football-specific task.
Players will dribble into a decision zone and respond to a late visual or situational cue by selecting and executing the optimal passing option.
The outcome will be expressed as the percentage of accurate decisions.
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Baseline and 28 days of supplementation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 août 2026
Achèvement primaire (Réel)
8 septembre 2026
Achèvement de l'étude (Réel)
8 septembre 2026
Dates d'inscription aux études
Première soumission
5 juillet 2026
Première soumission répondant aux critères de contrôle qualité
5 juillet 2026
Première publication (Réel)
10 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Symptômes comportementaux
- Fatigue
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Fatigue mentale
- Composés de soufre
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Lipides
- Hydrocarbures, acyclique
- Hydrocarbures
- Alcaloïdes
- Purinones
- Purines
- Alcanes
- Acides alcanesulfoniques
- Acides sulfoniques
- Acides de soufre
- Lipides membranaires
- Xanthines
- Glycérophospholipides
- Acides phosphatidiques
- Glycérophosphates
- Phospholipides
- Caféine
- Taurine
- Phosphatidylsérines
Autres numéros d'identification d'étude
- MIZERA -4-TCPS-FOOT-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
No individual participant data will be shared because the study includes a small sample of professional football players from a limited number of clubs, which may increase the risk of indirect participant identification.
Only aggregated and anonymized study results will be reported.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .