- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 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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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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30 m sprint time
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual reaction time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Krzysztof Maciej MIZERA, PhD, 1. Vizja University in Warsaw, Faculty of Medical Sciences and Health Sciences, 01-143 Warsaw, Poland
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MIZERA-FOOTBALL-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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