- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07696052
Phosphatidylserine, Taurine, and Caffeine for Cognitive Fatigue in Professional Football Players (TCPS-Foot)
Neurocognitive Fatigue Resistance, Visual Search Efficiency, and Tactical Decision-Making After Phosphatidylserine-Containing Taurine-Caffeine Supplementation in Professional Male Football Players
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is designed to determine whether adding phosphatidylserine to a taurine-caffeine supplementation strategy supports attentional control, efficient visual search, and accurate tactical decision-making under acute neurocognitive load in professional male football players.
Participants will complete familiarization, baseline laboratory testing, baseline field testing, 14 days of supplementation, post-intervention laboratory testing, and post-intervention field testing. The laboratory protocol will include a high-load Stroop/Flanker task followed by a football-specific video decision-making task with screen-based eye-tracking. The video task will include offensive and transitional football situations requiring players to select the most appropriate tactical option under time pressure. Some clips will require inhibition of an immediately attractive but suboptimal forward action.
The primary outcome will be the change in tactical inhibitory decision accuracy under neurocognitive load from baseline to post-intervention. Secondary outcomes will include overall decision accuracy, decision time, impulsive tactical errors, mental fatigue, Stroop/Flanker reaction-time variability, time to first fixation on the optimal option, dwell time on the optimal option, situational awareness accuracy, and field-based reactive passing decision performance. Field-based transfer will be assessed using a Reactive Passing Decision Test, the Loughborough Soccer Passing Test, and standardized small-sided games.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Krzysztof Maciej Mizera, PhD
- Telefonnummer: +48508356718
- E-mail: krzysztofmizera@o2.pl
Studiesteder
-
-
-
Lodz, Polen
- Professional Football Training Center
-
Kontakt:
- Krzysztof Mizera
- Telefonnummer: +48508356718
- E-mail: krzysztofmizera@o2.pl
-
Warsaw, Polen
- Professional Football Training Center
-
Kontakt:
- Krzysztof Mizera, PhD
- Telefonnummer: +48508356718
- E-mail: krzysztofmizera@o2.pl
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Participants randomized to this arm will receive an inert placebo for 14 days.
The placebo will be provided in identical coded packs matched for appearance, number of units, and packaging with the active supplements.
|
Inert placebo matched with the active supplements for appearance, number of units, and packaging.
The placebo will be administered for 14 days.
|
|
Aktiv komparator: Taurine Plus Caffeine
Participants randomized to this arm will receive taurine 1500 mg/day plus caffeine 200 mg/day for 14 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.
|
Taurine 1500 mg/day plus caffeine 200 mg/day administered for 14 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.
|
|
Eksperimentel: 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 14 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.
|
Taurine 1500 mg/day plus caffeine 200 mg/day plus phosphatidylserine 600 mg/day administered for 14 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Tactical Inhibitory Decision Accuracy Under Neurocognitive Load
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Overall Football-Specific Decision Accuracy
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Football-Specific Decision Time
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Impulsive Tactical Errors
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Stroop/Flanker Reaction-Time Variability
Tidsramme: Baseline and 14 days of supplementation
|
Reaction-time variability will be assessed during the high-load Stroop/Flanker task used to induce neurocognitive load.
The task will assess attentional control, response inhibition, conflict monitoring, and reaction-time stability.
The outcome will be expressed in milliseconds.
|
Baseline and 14 days of supplementation
|
|
Change in Post-Task Mental Fatigue
Tidsramme: Baseline and 14 days of supplementation
|
Mental fatigue will be assessed immediately after the neurocognitive load task using a visual analogue scale.
The scale will range from 0 to 10, with higher scores indicating greater perceived mental fatigue.
|
Baseline and 14 days of supplementation
|
|
Change in Time to First Fixation on the Optimal Tactical Option
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Dwell Time on the Optimal Tactical Option
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Situational Awareness Accuracy
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
|
Change in Reactive Passing Decision Test Accuracy
Tidsramme: Baseline and 14 days of supplementation
|
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.
|
Baseline and 14 days of supplementation
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Træthed
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Mental træthed
- Svovlforbindelser
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Lipider
- Kulbrinter, acyklisk
- Kulbrinter
- Alkaloider
- Purinoner
- Puriner
- Alkaner
- Alkanesulfonsyrer
- Sulfonsyrer
- Svovlsyrer
- Membranlipider
- Xanthines
- Glycerophospholipider
- Phosphatidinsyrer
- Glycerophosphater
- Phospholipider
- Koffein
- Taurin
- Phosphatidylseriner
Andre undersøgelses-id-numre
- MIZERA -4-TCPS-FOOT-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mental træthed
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Aktiv, ikke rekrutterendeGenopretning | Organisering af sundhedsvæsenet | Mental Health Services | Mental SundhedsplejeFrankrig
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsIkke rekrutterer endnuMentalt helbred | Mental Sundhed Hjælp-Søgende | Mental Health LiteracyForenede Stater
-
Alexandria UniversityAfsluttetKognitiv fleksibilitet | Mental Sundhed Stigmatisering | Klinisk Beredskab | Mental SundhedsplejeuddannelseEgypten
-
Indiana UniversityCommunity Health Network; Boys & Girls Clubs of IndianapolisAfsluttetMental sundhed velvære 1 | Børns adfærd | Teenagers adfærd | Mental sundhed velvære 2Forenede Stater
-
Universidade do PortoInstituto de Ciências Biomédicas Abel SalazarIkke rekrutterer endnuPlejerbyrde | Familieplejere | Mental sundhedsfremme | Positiv Mental SundhedPortugal
-
University of MichiganNational Institute of General Medical Sciences (NIGMS)RekrutteringMental funktionForenede Stater
-
University of MichiganNational Institute of General Medical Sciences (NIGMS)Afsluttet
-
Arizona State UniversityIkke rekrutterer endnu
-
Efforia, IncTilmelding efter invitation
Kliniske forsøg med Placebo
-
SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
-
National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
-
AkesoIkke rekrutterer endnuAtopisk dermatitisKina
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
-
CellmedisMedical Network Sp. z o.o.RekrutteringHalsbrand | Regurgitation, Gastrisk | GERD (gastroøsofageal reflukssygdom) | NERDPolen
-
Texas A&M UniversityNutraboltAfsluttetGlukose og insulinrespons
-
Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
-
Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater