- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07696052
Phosphatidylserine, Taurine, and Caffeine for Cognitive Fatigue in Professional Football Players (TCPS-Foot)
9 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
65
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Lodz, Polonia
- Professional Football Training Center
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Warsaw, Polonia
- Professional Football Training Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore 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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Comparatore attivo: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Tactical Inhibitory Decision Accuracy Under Neurocognitive Load
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Football-Specific Optimal Decision Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
6 agosto 2026
Completamento primario (Effettivo)
8 settembre 2026
Completamento dello studio (Effettivo)
8 settembre 2026
Date di iscrizione allo studio
Primo inviato
5 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
5 luglio 2026
Primo Inserito (Effettivo)
10 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Sintomi comportamentali
- Fatica
- Condizioni patologiche, segni e sintomi
- Comportamento
- Segni e sintomi
- Stanchezza mentale
- Composti di zolfo
- Prodotti chimici organici
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Lipidi
- Idrocarburi, aciclici
- Idrocarburi
- Alcaloidi
- Purinoni
- Purine
- Alcani
- Acidi alcanesolfonici
- Acidi solfonici
- Acidi zolfo
- Lipidi a membrana
- Xantine
- Glicerofosfolipidi
- Acidi fosfatidici
- Glicerofosfati
- Fosfolipidi
- Caffeina
- Taurina
- Fosfatidilserine
Altri numeri di identificazione dello studio
- MIZERA -4-TCPS-FOOT-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .