- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07604519
Multi-Ingredient Supplementation in Professional Football Players (TCP-Soccer)
Dose-Dependent Effects of Multi-Ingredient Supplementation on Physical Performance, Recovery, and Cognitive Function in Professional Football Players
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The planned study will be a randomized, double-blind, placebo-controlled trial designed as a continuation and extension of previous research on multi-ingredient supplementation in professional football players. The primary aim will be to investigate the dose-dependent effects of phosphatidylserine combined with taurine and caffeine under standardized football-specific training conditions and acute cognitive-fatigue conditions.
Approximately 80 professional male football players competing at national level will be randomly assigned to four groups: placebo, taurine + caffeine, taurine + caffeine + phosphatidylserine 300 mg, and taurine + caffeine + phosphatidylserine 600 mg. Importantly, caffeine and taurine doses will remain identical across all active supplementation groups in order to enable a more precise evaluation of the independent effects of phosphatidylserine.
Participants will complete a 14-day supplementation protocol and undergo baseline and post-intervention assessments including 30 m sprint performance, reaction time, cognitive-fatigue responses, football-specific GPS monitoring, fatigue-related performance decline, recovery-related variables, sleep monitoring, and autonomic nervous system activity assessment.
The study is expected to provide novel insights into the role of phosphatidylserine in football-specific performance, cognitive fatigue resistance, recovery, and neurophysiological responses in elite football players.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
-
Inclusion Criteria:
- Professional male football players aged 18-35 years
- Regular participation in team training and competitive matches
- Clinically healthy status confirmed prior to participation
- Written informed consent provided
Exclusion Criteria:
- Current musculoskeletal injury or illness
- Chronic metabolic, cardiovascular, or neurological disease
- Regular medication use
- Current use of dietary supplements or ergogenic aids
- Smoking or excessive alcohol consumption
- Known hypersensitivity to any study supplement ingredient
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: P
Participants will receive visually identical placebo capsules for 14 days.
|
Placebo capsules administered daily during the 14-day intervention period
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Eksperimentel: TC
Participants will receive taurine (1500 mg/day) and caffeine (200 mg/day) supplementation for 14 days.
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Taurine supplementation administered daily during the 14-day intervention period.
Caffeine supplementation administered daily during the 14-day intervention period.
|
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Eksperimentel: TCP-300
Participants will receive taurine (1500 mg/day), caffeine (200 mg/day), and phosphatidylserine (300 mg/day) supplementation for 14 days.
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Taurine supplementation administered daily during the 14-day intervention period.
Caffeine supplementation administered daily during the 14-day intervention period.
Phosphatidylserine supplementation administered daily during the 14-day intervention period.
|
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Eksperimentel: TCP-600
Participants will receive taurine (1500 mg/day), caffeine (200 mg/day), and phosphatidylserine (600 mg/day) supplementation for 14 days.
|
Taurine supplementation administered daily during the 14-day intervention period.
Caffeine supplementation administered daily during the 14-day intervention period.
Phosphatidylserine supplementation administered daily during the 14-day intervention period.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
30 m sprint time
Tidsramme: Baseline and after 14 days of supplementation
|
Time required to complete a 30 m sprint, measured using electronic timing gates. The best result from three maximal sprint trials will be used for analysis. Unit of Measure: seconds |
Baseline and after 14 days of supplementation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual reaction time
Tidsramme: Baseline and after 14 days of supplementation
|
Mean response time to a visual stimulus, measured using a validated visual reaction time test.
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Baseline and after 14 days of supplementation
|
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Auditory reaction time
Tidsramme: Baseline and after 14 days of supplementation
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Mean response time to an auditory stimulus, measured using a computerized auditory reaction time test.
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Baseline and after 14 days of supplementation
|
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Total distance covered
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
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Total distance covered during the standardized football-specific training session, measured using a 10-Hz GPS tracking system. Unit of Measure: meters |
After 14 days of supplementation, during the standardized football-specific training session
|
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Relative distance
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
|
Distance covered per minute during the standardized football-specific training session, measured using a 10-Hz GPS tracking system. Unit of Measure: meters per minute |
After 14 days of supplementation, during the standardized football-specific training session
|
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High-speed running distance
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
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Description: Distance covered at running speeds above 19.8 km/h during the standardized football-specific training session, measured using a 10-Hz GPS tracking system. Unit of Measure: meters |
After 14 days of supplementation, during the standardized football-specific training session
|
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Number of sprints
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
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Total number of sprint efforts performed during the standardized football-specific training session. Sprinting will be defined as running speed above 25.0 km/h and measured using a 10-Hz GPS tracking system. Unit of Measure: number of sprints |
After 14 days of supplementation, during the standardized football-specific training session
|
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Player Load
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
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External training load during the standardized football-specific training session, measured using triaxial accelerometry integrated with the GPS tracking system. Unit of Measure: arbitrary units |
After 14 days of supplementation, during the standardized football-specific training session
|
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Heart rate variability RMSSD
Tidsramme: Daily during the 14-day supplementation period
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Resting heart rate variability assessed in the morning using the root mean square of successive differences between normal heartbeats.
HRV will be measured using a heart rate sensor or wearable device under standardized resting conditions.
Unit of Measure: milliseconds
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Daily during the 14-day supplementation period
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Sleep duration
Tidsramme: Daily during the 14-day supplementation period
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Total sleep duration assessed using wearable sleep monitoring.
Unit of Measure: hours
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Daily during the 14-day supplementation period
|
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Sleep efficiency
Tidsramme: Daily during the 14-day supplementation period
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Percentage of time in bed spent asleep, assessed using wearable sleep monitoring. Unit of Measure: percent |
Daily during the 14-day supplementation period
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Subjective fatigue
Tidsramme: Daily during the 14-day supplementation period
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Subjective fatigue assessed using the fatigue item of the Hooper Index questionnaire on a 1-7 scale, where higher values indicate greater fatigue.
Unit of Measure: score on a scale
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Daily during the 14-day supplementation period
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Muscle soreness
Tidsramme: Daily during the 14-day supplementation period
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Perceived lower-limb muscle soreness assessed using a 0-10 delayed onset muscle soreness scale, where higher values indicate greater soreness. Unit of Measure: score on a scale |
Daily during the 14-day supplementation period
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Stroop task reaction time
Tidsramme: Baseline and after 14 days of supplementation
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Mean response time during a modified computerized Stroop task assessing cognitive fatigue, inhibitory control, sustained attention, and information processing speed.
Unit of Measure: seconds
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Baseline and after 14 days of supplementation
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Stroop task accuracy
Tidsramme: Baseline and after 14 days of supplementation
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Percentage of correct responses during a modified computerized Stroop task.
Unit of Measure: percent
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Baseline and after 14 days of supplementation
|
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Stroop task error rate
Tidsramme: Baseline and after 14 days of supplementation
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Number of incorrect responses during a modified computerized Stroop task.
Unit of Measure: number of errors
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Baseline and after 14 days of supplementation
|
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Perceived mental fatigue
Tidsramme: Baseline and after 14 days of supplementation
|
Subjective perceived mental fatigue assessed using a 0-10 visual analogue scale, where higher values indicate greater perceived mental fatigue.
Unit of Measure: score on a 0-10 scale
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Baseline and after 14 days of supplementation
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Change in sprint count between first and second half
Tidsramme: After 14 days of supplementation, during the standardized football-specific training session
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Percentage decline in the number of sprints between the first and second half of the standardized football-specific training session. Sprint change will be calculated as: [(second half value - first half value) / first half value] × 100. Unit of Measure: percent |
After 14 days of supplementation, during the standardized football-specific training session
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Krzysztof Maciej MIZERA, PhD, 1. Vizja University in Warsaw, Faculty of Medical Sciences and Health Sciences, 01-143 Warsaw, Poland
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- 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-FOOTBALL-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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