- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07696052
Phosphatidylserine, Taurine, and Caffeine for Cognitive Fatigue in Professional Football Players (TCPS-Foot)
9 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
65
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Lodz, Polska
- Professional Football Training Center
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Warsaw, Polska
- Professional Football Training Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Komparator 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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Aktywny komparator: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Tactical Inhibitory Decision Accuracy Under Neurocognitive Load
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Overall Football-Specific Optimal Decision Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
6 sierpnia 2026
Zakończenie podstawowe (Rzeczywisty)
8 września 2026
Ukończenie studiów (Rzeczywisty)
8 września 2026
Daty rejestracji na studia
Pierwszy przesłany
5 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 lipca 2026
Pierwszy wysłany (Rzeczywisty)
10 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 września 2026
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy behawioralne
- Zmęczenie
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Objawy i symptomy
- Zmęczenie psychiczne
- Związki siarki
- Organiczne chemikalia
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Lipidy
- Węglowodory, acykliczne
- Węglowodory
- Alkaloidy
- Puryny
- Puryny
- Alkan
- Kwasy alkanesulfonowe
- Kwasy sulfonowe
- Kwasy siarkowe
- Lipidy błony
- Ksantiny
- Glicerofosfolipidy
- Kwasy fosfatydowe
- Glicerofosforany
- Fosfolipidy
- Kofeina
- Byczy
- Fosfatydyloseryny
Inne numery identyfikacyjne badania
- MIZERA -4-TCPS-FOOT-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .