- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07696052
Phosphatidylserine, Taurine, and Caffeine for Cognitive Fatigue in Professional Football Players (TCPS-Foot)
9. september 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
65
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lodz, Polen
- Professional Football Training Center
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Warsaw, Polen
- Professional Football Training Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: 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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Aktiv 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Tactical Inhibitory Decision Accuracy Under Neurocognitive Load
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Football-Specific Optimal Decision Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. august 2026
Primær fullføring (Faktiske)
8. september 2026
Studiet fullført (Faktiske)
8. september 2026
Datoer for studieregistrering
Først innsendt
5. juli 2026
Først innsendt som oppfylte QC-kriteriene
5. juli 2026
Først lagt ut (Faktiske)
10. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Atferdssymptomer
- Utmattelse
- Patologiske tilstander, tegn og symptomer
- Oppførsel
- Tegn og symptomer
- Mental tretthet
- Svovelforbindelser
- Organiske kjemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Lipider
- Hydrokarboner, acyklisk
- Hydrokarboner
- Alkaloider
- Purinoner
- Puriner
- Alkaner
- Alkanesulfonsyrer
- Sulfonsyrer
- Svovelsyrer
- Membranlipider
- Xantiner
- Glyserofosfolipider
- Fosfatidiske syrer
- Glyserofosfater
- Fosfolipider
- Koffein
- Taurine
- Fosfatidylseriner
Andre studie-ID-numre
- MIZERA -4-TCPS-FOOT-2026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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