- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07710547
TCP-600 Supplementation and Performance Response in Professional Football Players (TCP600-RESP)
Multidimensional Responses to Taurine-Caffeine Supplementation With and Without Phosphatidylserine in Professional Football Players: A 28-Day Randomised, Placebo- and Active-Controlled Trial
This 28-day randomised, placebo- and active-controlled trial investigated multidimensional responses to taurine-caffeine supplementation with or without phosphatidylserine in 65 male professional and highly trained football players.
Participants were allocated to placebo (PLA), taurine 1500 mg/day plus caffeine 200 mg/day (TC), or the same combination supplemented with phosphatidylserine 600 mg/day (TCP-600). Assessments were conducted before and after the intervention and covered physical performance, cognitive function, cardiac autonomic modulation and football-specific perceptual-cognitive performance.
The primary outcome was the proportion of participants showing favourable responses in at least two of four predefined assessment domains. The principal treatment comparison was TCP-600 versus TC, with comparisons involving placebo providing additional information on the effects of supplementation.
Обзор исследования
Статус
Условия
Подробное описание
This randomised, masked, placebo- and active-controlled trial examined physical, cognitive, autonomic and football-specific perceptual-cognitive responses to 28 days of supplementation in professional and highly trained male football players.
Participants were randomly allocated to placebo (PLA), taurine 1500 mg/day plus caffeine 200 mg/day (TC), or taurine 1500 mg/day plus caffeine 200 mg/day and phosphatidylserine 600 mg/day (TCP-600). Assessments were performed before supplementation and after the intervention.
The primary outcome was the proportion of multidimensional responders, defined as participants meeting favourable-response criteria in at least two of four assessment domains: physical performance, cognitive performance, autonomic/recovery-related response and football-specific perceptual-cognitive performance.
Secondary assessments included 30 m sprint performance, cognitive reaction time, cardiac autonomic modulation assessed using LnRMSSD, readiness to train, perceived fatigue, football-specific decision-making, response time and visual search behaviour. The study also monitored supplementation adherence and adverse events.
The principal treatment comparison was TCP-600 versus TC, allowing assessment of the additional effect of phosphatidylserine within a fixed taurine-caffeine supplementation regimen. Comparisons with placebo were also conducted.
Post-completion clarification (November 2026): The original registration included external validation of a previously developed responder prediction model, with AUROC as a secondary outcome. This analysis was not performed because a previously finalised prediction model suitable for independent validation was unavailable. The analysis therefore focuses on observed multidimensional response and treatment-group comparisons. The omission of the originally registered prediction-model validation analysis is disclosed as a deviation from the initial analysis plan.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Krakow, Польша
- Professional Football Training Center
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Lodz, Польша, 01-043
- Professional Football Training Center
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Warsaw, Польша, 01-043
- Professional Football Training Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male professional or highly trained football players aged 18-37 years.
- Regular participation in structured football training and team activities.
- Minimum of 5 years of structured football training experience.
- Regular involvement in club training during the study period.
- Medical clearance or no known contraindications to high-intensity exercise testing.
- Ability to complete sprint, reaction-time, cognitive-fatigue, heart-rate-variability, wellness/readiness, and selected football-specific perceptual-cognitive assessments where available.
- Willingness to maintain usual diet and training habits during the study period.
- Willingness to avoid additional ergogenic supplements outside the study protocol during the intervention.
- Willingness to follow caffeine restrictions before testing sessions.
- Written informed consent provided before participation.
Exclusion Criteria:
- Current musculoskeletal injury or illness preventing full participation in training or testing.
- Musculoskeletal injury within the previous 3 months that may affect sprint, football-specific performance, or perceptual-cognitive testing.
- Cardiovascular, metabolic, neurological, psychiatric, or other chronic disease that may affect safety or study outcomes.
- Diagnosed sleep disorder.
- Use of medication affecting heart rate, autonomic nervous system function, sleep, cognition, or exercise performance.
- Known hypersensitivity or intolerance to caffeine, taurine, phosphatidylserine, or any supplement ingredient.
- Regular use of ergogenic supplements that cannot be discontinued before and during the study period.
- Smoking or regular use of nicotine products.
- Participation in another interventional study during the same period.
- Inability to comply with supplementation, monitoring, or testing procedures.
- Failure to provide written informed consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Placebo
Participants assigned to this arm will receive placebo capsules for 28 consecutive days. Placebo capsules will be matched to the active supplement in appearance, number, packaging, and administration schedule. |
Matching placebo capsules administered orally once daily for 28 consecutive days. The placebo was matched to the active supplements in appearance, number, packaging, and administration schedule. |
|
Активный компаратор: Taurine + Caffeine
Participants assigned to this arm will receive taurine 1500 mg/day and anhydrous caffeine 200 mg/day, administered orally once daily for 28 consecutive days. Matching placebo capsules will be used to maintain the same total number and appearance of capsules across study arms. |
Taurine 1500 mg/day administered orally once daily in capsules for 28 consecutive days. Anhydrous caffeine 200 mg/day administered orally once daily in capsules for 28 consecutive days. |
|
Экспериментальный: Taurine + Caffeine + Phosphatidylserine
Participants assigned to this arm will receive a multi-ingredient supplementation protocol containing taurine 1500 mg/day, anhydrous caffeine 200 mg/day, and phosphatidylserine 600 mg/day, administered orally once daily for 28 consecutive days. This intervention is referred to as the TCP-600 protocol. |
Taurine 1500 mg/day administered orally once daily in capsules for 28 consecutive days. Anhydrous caffeine 200 mg/day administered orally once daily in capsules for 28 consecutive days. Phosphatidylserine 600 mg/day administered orally once daily in capsules for 28 consecutive days. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Proportion of Participants Classified as Multidimensional Responders After 28 Days
Временное ограничение: Baseline to post-intervention after 28 days of supplementation
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Proportion of participants classified as multidimensional responders after 28 days of supplementation. A multidimensional responder will be defined as a participant meeting the predefined response criterion in at least two of four domains: physical performance/fatigue resistance, cognitive fatigue-related performance, recovery/readiness, and football-specific perceptual-cognitive performance. The outcome will be reported as the percentage of participants classified as multidimensional responders in each group. Unit of Measure: percentage of participants |
Baseline to post-intervention after 28 days of supplementation
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in 30 m Sprint Time
Временное ограничение: Baseline to post-intervention after 28 days of supplementation
|
Change in 30 m sprint performance from baseline to post-intervention testing. Sprint time will be measured using electronic timing gates. Participants will perform three maximal 30 m sprint trials separated by standardized recovery periods, and the best valid trial will be used for analysis. |
Baseline to post-intervention after 28 days of supplementation
|
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Change in Cognitive Fatigue Task Reaction Time
Временное ограничение: Baseline to post-intervention after 28 days of supplementation
|
Change in reaction time during the computerized cognitive fatigue task from baseline to post-intervention testing after 28 days of supplementation. Reaction time will be measured during the predefined cognitive task performed under cognitive load. The outcome will be reported as the mean change in reaction time from baseline to post-intervention testing. Lower values indicate faster cognitive responses. Unit of Measure: milliseconds |
Baseline to post-intervention after 28 days of supplementation
|
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Change in Perceived Mental Fatigue VAS Score
Временное ограничение: Baseline to post-intervention after 28 days of supplementation.
|
Change in perceived mental fatigue from baseline to post-intervention testing after 28 days of supplementation. Perceived mental fatigue will be assessed using a 0-10 visual analogue scale, where 0 indicates no perceived mental fatigue and 10 indicates maximal perceived mental fatigue. The outcome will be reported as the mean change in score from baseline to post-intervention testing. Higher scores indicate greater perceived mental fatigue. Unit of Measure: points on a 0-10 scale |
Baseline to post-intervention after 28 days of supplementation.
|
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Change in Final 3-Day Mean LnRMSSD
Временное ограничение: Baseline monitoring period to final 3 days of supplementation.
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Change in heart rate variability from baseline monitoring to the final 3 days of supplementation. Heart rate variability will be expressed as the natural logarithm of the root mean square of successive RR interval differences. Morning HRV will be recorded under standardized resting conditions. The outcome will be reported as the mean change in final 3-day mean LnRMSSD compared with the baseline monitoring period. Unit of Measure: ln(ms) |
Baseline monitoring period to final 3 days of supplementation.
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Change in Readiness-to-Train Rating Scale Score
Временное ограничение: Baseline monitoring period to final 3 days of supplementation.
|
Change in self-reported readiness to train from baseline monitoring to the final 3 days of supplementation. Readiness to train will be assessed using a single-item readiness-to-train rating scale scored from 1 to 10, where 1 indicates very poor readiness and 10 indicates excellent readiness. The outcome will be reported as the mean change in readiness-to-train score from the baseline monitoring period to the final 3-day supplementation period. Higher scores indicate greater perceived readiness to train. Unit of Measure: points on a 1-10 scale |
Baseline monitoring period to final 3 days of supplementation.
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Change in Hooper and Mackinnon Wellness Questionnaire Fatigue Item Score
Временное ограничение: Baseline monitoring period to final 3 days of supplementation.
|
Change in self-reported fatigue from baseline monitoring to the final 3 days of supplementation. Fatigue will be assessed using the fatigue item of the Hooper and Mackinnon wellness questionnaire. The item is scored on a 1-7 scale. The outcome will be reported as the mean change in fatigue item score from the baseline monitoring period to the final 3-day supplementation period. Higher scores indicate greater perceived fatigue. Unit of Measure: points on a 1-7 scale |
Baseline monitoring period to final 3 days of supplementation.
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Area Under the Receiver Operating Characteristic Curve for the Predefined Responder Model
Временное ограничение: Post-intervention after 28 days of supplementation.
|
Predictive performance of the predefined responder model in the independent validation cohort will be assessed using the area under the receiver operating characteristic curve. The model will compare predicted responder status with observed multidimensional responder status after 28 days of supplementation. Higher values indicate better discrimination. Unit of Measure: area under the curve Post-completion clarification (November 2026): The originally planned AUROC analysis was not performed because a previously finalised prediction model was not available for independent validation. No prediction model was developed using the present cohort as a substitute. This deviation from the original analysis plan will be disclosed in the study publication. |
Post-intervention after 28 days of supplementation.
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Number of Participants With Supplement-Related Adverse Events
Временное ограничение: During the 28-day supplementation period
|
Number of participants reporting at least one supplement-related adverse event during the 28-day supplementation period. Participants will be asked to report gastrointestinal symptoms, sleep disturbances, headache, palpitations, nervousness, or any other unusual symptoms. Unit of Measure: participants |
During the 28-day supplementation period
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Change in Football-Specific Video Decision-Making Task Response Time
Временное ограничение: Baseline to post-intervention after 28 days of supplementation.
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Change in response time during the football-specific video decision-making task from baseline to post-intervention testing after 28 days of supplementation. Response time will be measured as the time from presentation of the decision prompt to participant response. The outcome will be reported as the mean change in response time from baseline to post-intervention testing. Lower values indicate faster football-specific decision-making. Unit of Measure: milliseconds |
Baseline to post-intervention after 28 days of supplementation.
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Change in Football-Specific Video Decision-Making Task Accuracy
Временное ограничение: Baseline to post-intervention after 28 days of supplementation.
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Change in football-specific decision-making accuracy from baseline to post-intervention testing after 28 days of supplementation. Decision-making accuracy will be assessed using a football-specific video decision-making task. Participants will view standardized football-specific scenarios and select the most appropriate tactical decision. The outcome will be reported as the mean change in the percentage of correct decisions from baseline to post-intervention testing. Higher values indicate better football-specific decision-making accuracy. Unit of Measure: percentage of correct decisions |
Baseline to post-intervention after 28 days of supplementation.
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Change in Eye-Tracking Time to First Fixation on the Optimal Tactical Option
Временное ограничение: Baseline to post-intervention after 28 days of supplementation.
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Change in visual search behavior from baseline to post-intervention testing after 28 days of supplementation. Visual search behavior will be assessed using eye-tracking during the football-specific video decision-making task. Time to first fixation will be defined as the time from scenario onset to the first fixation on the predefined optimal tactical option. The outcome will be reported as the mean change in time to first fixation from baseline to post-intervention testing. Lower values indicate faster visual orientation toward the optimal tactical option. Unit of Measure: milliseconds |
Baseline to post-intervention after 28 days of supplementation.
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Поведенческие симптомы
- Усталость
- Патологические состояния, признаки и симптомы
- Поведение
- Признаки и симптомы
- Умственная усталость
- Средние соединения
- Органические химические вещества
- Гетероциклические соединения
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Липиды
- Углеводороды, ациклические
- Углеводороды
- Алкалоиды
- Пуриноны
- Пурины
- Алканы
- Алкансульфоновые кислоты
- Сульфоновые кислоты
- Серные кислоты
- Мембранные липиды
- Ксантины
- Глицерофосфолипиды
- Фосфатидные кислоты
- Глицерофосфаты
- Фосфолипиды
- Кофеин
- Таурин
- Фосфатидилсерины
Другие идентификационные номера исследования
- VIZJA-TCP600-RESP-2026 (28)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Individual participant data will not be publicly shared due to participant confidentiality and the small, potentially identifiable nature of the professional athlete sample. Aggregated results may be reported in publications. Selected anonymized analysis outputs may be made available from the corresponding author upon reasonable request, where ethically and legally appropriate.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .