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Набор скоро начнётся NCT07710547

TCP-600 Supplementation and Performance Response in Professional Football Players

Без фазы С лечением Athletic Performance Cognitive Fatigue Exercise Recovery Football-Specific Performance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Placebo, Taurine, Caffeine, Phosphatidylserine.
Кому может быть актуально
Состояния в реестре: Athletic Performance, Cognitive Fatigue, Exercise Recovery, Football-Specific Performance. Базовые параметры: 18 лет — 36 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

External Validation and Extension of Physical, Recovery, and Perceptual-Cognitive Responder Profiles After Phosphatidylserine-Containing Taurine-Caffeine Supplementation in Professional Football Players: A Randomized, Double-Blind, Placebo-Controlled Trial

Обзор

This study will examine whether a 28-day supplementation protocol containing taurine, caffeine, and phosphatidylserine can help professional male football players maintain physical performance, cognitive function, recovery-related readiness, and selected football-specific perceptual-cognitive performance. Participants will be randomly assigned to receive either placebo or a phosphatidylserine-containing multi-ingredient supplement. Before and after the supplementation period, players will complete non-invasive assessments such as sprint testing, reaction-time testing, heart rate variability monitoring, wellness/readiness questionnaires, mental-fatigue measures, and selected football-specific perceptual-cognitive tasks where available. The study is designed as an external validation and extension of responder profiles derived from previous randomized controlled trials. Data from previous trials and this validation cohort will be used to examine whether baseline physical, cognitive, autonomic, fatigue-related, recovery-related, or perceptual-cognitive characteristics can predict which players are most likely to benefit from phosphatidylserine-containing multi-ingredient supplementation.

Подробное описание

This is a randomized, double-blind, placebo-controlled validation study conducted in professional male football players. The study is designed to externally validate and extend individual responder profiles previously derived from randomized controlled trials investigating taurine-, caffeine-, and phosphatidylserine-containing supplementation in professional football players.

Participants in the validation cohort will be randomly assigned to receive either placebo or a phosphatidylserine-containing multi-ingredient supplement containing taurine, caffeine, and phosphatidylserine. Phosphatidylserine will be provided at a dose of 600 mg per day. The supplementation period will last 28 days. The placebo will be matched as closely as possible in appearance, number of units, packaging, and administration schedule.

The main aim of the study is to determine whether baseline characteristics can help identify players who are more likely to respond positively to the supplementation protocol. The multidimensional responder profile will include predefined domains related to physical performance and fatigue resistance, cognitive and mental fatigue-related outcomes, recovery/readiness-related outcomes, and selected football-specific perceptual-cognitive performance.

Before and after the supplementation period, participants will complete non-invasive assessments. These may include 30 m sprint performance, simple or choice reaction time, computerized cognitive tasks, mental fatigue ratings, heart rate variability indices such as LnRMSSD, wellness/readiness questionnaires, sleep quality, perceived fatigue, and selected football-specific performance variables where available.

The perceptual-cognitive domain may include football-specific decision-making accuracy, response time, tactical inhibitory decision-making under cognitive load, situational awareness, visual search-related variables, and selected field-transfer outcomes where available. These measures will be used to explore whether players who respond favorably in physical or recovery-related domains also show favorable responses in cognitive fatigue resistance, decision-making, or perceptual-cognitive football performance.

No blood, saliva, urine, genetic material, or other biological samples will be collected. All assessments will be non-invasive. The validation cohort will test whether responder profiles developed from previous trials can be applied to an independent group of professional football players. The study may support a more individualized approach to performance nutrition by identifying whether baseline autonomic, cognitive, fatigue-related, recovery-related, or perceptual-cognitive characteristics are associated with a greater likelihood of response to phosphatidylserine-containing multi-ingredient supplementation.

Вмешательства

  • Другое Placebo
    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.
  • Пищевая добавка Taurine
    Taurine 1500 mg/day administered orally once daily in capsules for 28 consecutive days.
  • Пищевая добавка Caffeine
    Anhydrous caffeine 200 mg/day administered orally once daily in capsules for 28 consecutive days.
  • Пищевая добавка Phosphatidylserine
    Phosphatidylserine 600 mg/day administered orally once daily in capsules for 28 consecutive days.

Первичные конечные точки

  • Proportion of Participants Classified as Multidimensional Responders After 28 Days [Срок оценки: Baseline to post-intervention after 28 days of supplementation]
Вторичные конечные точки (11)
  • Change in 30 m Sprint Time [Срок оценки: Baseline to post-intervention after 28 days of supplementation]
  • Change in Cognitive Fatigue Task Reaction Time [Срок оценки: Baseline to post-intervention after 28 days of supplementation]
  • Change in Perceived Mental Fatigue VAS Score [Срок оценки: Baseline to post-intervention after 28 days of supplementation.]
  • Change in Final 3-Day Mean LnRMSSD [Срок оценки: Baseline monitoring period to final 3 days of supplementation.]
  • Change in Readiness-to-Train Rating Scale Score [Срок оценки: Baseline monitoring period to final 3 days of supplementation.]
  • Change in Hooper and Mackinnon Wellness Questionnaire Fatigue Item Score [Срок оценки: Baseline monitoring period to final 3 days of supplementation.]
  • Area Under the Receiver Operating Characteristic Curve for the Predefined Responder Model [Срок оценки: Post-intervention after 28 days of supplementation.]
  • Number of Participants With Supplement-Related Adverse Events [Срок оценки: During the 28-day supplementation period]
  • Change in Football-Specific Video Decision-Making Task Response Time [Срок оценки: Baseline to post-intervention after 28 days of supplementation.]
  • Change in Football-Specific Video Decision-Making Task Accuracy [Срок оценки: Baseline to post-intervention after 28 days of supplementation.]
  • Change in Eye-Tracking Time to First Fixation on the Optimal Tactical Option [Срок оценки: Baseline to post-intervention after 28 days of supplementation.]

Критерии участия

Критерии включения

  • Male professional or highly trained football players aged 18-36 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

Польша · 3 центра
  • Professional Football Training Center — Krakow
  • Professional Football Training Center — Lodz
  • Professional Football Training Center — Warsaw

Идентификаторы

NCT: NCT07710547 · VIZJA-TCP600-RESP-2026 (28)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗