- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Budapest, Maďarsko
- Professional Football Training Center
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Lodz, Polsko
- Professional Football Training Center
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Warsaw, Polsko
- Professional Football Training Center
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Wroclaw, Polsko
- Professional Football Training Center
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Alicante, Španělsko
- Professional Football Training Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
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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:
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: P
Participants will receive visually identical placebo capsules for 14 days.
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Placebo capsules administered daily during the 14-day intervention period
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Experimentální: 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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Experimentální: 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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Experimentální: TCP-600
Participants will receive taurine (1500 mg/day), caffeine (200 mg/day), and phosphatidylserine (600 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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30 m sprint time
Časové okno: Baseline and after 14 days of supplementation
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual reaction time
Časové okno: Baseline and after 14 days of supplementation
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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
Časové okno: 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
Časové okno: 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
Časové okno: After 14 days of supplementation, during the standardized football-specific training session
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline and after 14 days of supplementation
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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
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Krzysztof Maciej MIZERA, PhD, 1. Vizja University in Warsaw, Faculty of Medical Sciences and Health Sciences, 01-143 Warsaw, Poland
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Únava
- Sloučeniny síry
- Organické chemikálie
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, 2-prsten
- Heterocyklické sloučeniny, fúzované kroužek
- Lipidy
- Uhlovodíky, acyklické
- Uhlovodíky
- Alkaloidy
- Purinony
- Puriny
- Alkany
- Alkanesulfonové kyseliny
- Kyseliny sulfonové
- Kyseliny síry
- Membránové lipidy
- Xantines
- Glycerofosfolipidy
- Kyseliny fosfatidové
- Glycerofosfáty
- Fosfolipidy
- Kofein
- Taurine
- Fosfatidylseriny
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- MIZERA-FOOTBALL-2026
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Popis plánu IPD
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