- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07690124
S-Acetyl Glutathione and Performance Recovery in Soccer
Pharmacodynamics & Pharmacokinetics Study of S-Acetyl Glutathione in Highly Trained Soccer Players
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Following baseline testing [including assessment of anthropometrics, body composition (via DXA instrumentation) and physical performance (cardiorespiratory fitness, drop jump and countermovement jump performance, repeated sprint anility, isokinetic peak torque)], 20 well-trained, soccer players will participate in three trials, receiving daily (i) 200 mg SAG, (ii) 500 mg SAG or (iii) Placebo, according to a randomized, double-blind, crossover, repeated-measures design. The duration of each trial will be 11 days, including a 7-day pre-loading period (days 1 -7), a match day (day 8) and 3 consecutive recovery days after the match (days 9-11). Between trials a 3-week washout period will be implemented.
Pre-loading period: During the 7-day pre-loading period players will participate daily in training sessions according to a soccer-specific weekly training schedule, while receiving the respective supplement. Blood samples will be collected on day 1 and day 7 while daily nutrient intake (via 7-day diet recalls), physical activity level (via accelerometry) and training load (via global positioning system instrumentation during training sessions) will be monitored daily.
Match day: On match day, players will participate in an official 90-min soccer match. Field activity (total distance, average and maximum speed, high intensity running, high speed running, accelerations, decelerations) and heart rate (mean and maximum heart rate) will be continuously monitored using global positioning system (GPS) and heart rate monitors, respectively.
Recovery days: During the 3-day recovery period after the match, players will participate daily in (i) morning testing sessions and (ii) training sessions in the evening. Testing sessions will include blood sampling and performance measurements including drop jump and countermovement jump performance, repeated sprint anility, isokinetic peak torque and muscle soreness (DOMS). Dietary intake (via a 3-day diet recalls), physical activity level (via accelerometry) and training load (via GPS instrumentation during training sessions) will be monitored daily.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dimitrios Draganidis, PhD
- Número de teléfono: +30 2431047078
- Correo electrónico: ddraganidis@uth.gr
Copia de seguridad de contactos de estudio
- Nombre: Athanasios Poulios, PhD
- Número de teléfono: +30 2431047053
- Correo electrónico: athanpoul@gmail.com
Ubicaciones de estudio
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Karies
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Trikala, Karies, Grecia, 42100
- Department of Physical Education and Sport Science, University of Thessaly
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Contacto:
- Ioannis G Fatouros, PhD
- Número de teléfono: +30 2431047047
- Correo electrónico: ifatouros@uth.gr
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Contacto:
- Athanasios Z Jamurtas, PhD
- Número de teléfono: +30 24310 47054
- Correo electrónico: ajamurt@uth.gr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- participation at elite (top three division leagues) for ≥ 4 years
- no recent history of febrile illness, musculoskeletal problems and metabolic diseases
- no consumption of medications and performance-enhancing supplements (including anti-inflammatory, antioxidants, vitamins and multivitamin supplements) for at least 6 months prior to the study
- participation in at least 5 training sessions and 1 match per week
- non-smokers
Exclusion Criteria:
- musculoskeletal injury
- consumption of medication and performance-enhancing supplements
- illness during the course of the study
- loss of follow-up measurements
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: SAG-200 Trial
Oral administration of S-Acetyl Glutathione (SAG)
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Participants will be supplemented daily with 200 mg of S-acetyl glutathione, orally, over the 11-day experimental period.
|
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Experimental: SAG-500 Trial
Oral administration of S-Acetyl Glutathione (SAG)
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Participants will be supplemented daily with 500 mg of S-acetyl glutathione, orally, over the 11-day experimental period.
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Comparador de placebos: Placebo Trial
Oral administration of placebo
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Participants will be supplemented daily with placebo, orally, over the 11-day experimental period.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in creatine kinase levels
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Creatine kinase concentration will be measured in serum using a Clinical Chemistry Analyzer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in myoglobin levels
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Myoglobin concentration will be measured in serum using a Clinical Chemistry Analyzer
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Day 1, day 7, day 9, day 10 and day 11
|
|
Change in reduced glutathione
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Reduced glutathione will be photometrically determined in red blood cell lysates using a spectrophotometer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in oxidized glutathione
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Oxidized glutathione will be photometrically determined in red blood cell lysates using a spectrophotometer
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Day 1, day 7, day 9, day 10 and day 11
|
|
Change in glutathione reductase activity
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Glutathione reductase activity will be photometrically determined in red blood cell lysates using a spectrophotometer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in glutathione peroxidase activity
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11.
|
Glutathione peroxidase activity will be photometrically determined in red blood cell lysates using a spectrophotometer
|
Day 1, day 7, day 9, day 10 and day 11.
|
|
Change in catalase activity
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Catalase activity will be photometrically determined in red blood cell lysates using a spectrophotometer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in superoxide dismutase activity
Periodo de tiempo: Day 1, day 7, day 9, day 10 and day 11
|
Superoxide dismutase activity will be photometrically determined in red blood cell lysates using a spectrophotometer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in maximal voluntary isometric contraction
Periodo de tiempo: Day 1, day 9, day 10 and day 11
|
Maximal voluntary isometric contraction will be assessed at a 60o knee joint angle, in both dominant and non-dominant limb, using an isokinetic dynamometer
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Day 1, day 9, day 10 and day 11
|
|
Change in maximal peak torque
Periodo de tiempo: Day 1, day 9, day 10 and day 11
|
Maximal concentric and eccentric peak torque at 60o/s of the knee extensors and flexors in both dominant and non-dominant limb, will be assessed on an isokinetic dynamometer
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Day 1, day 9, day 10 and day 11
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|
Change in jumping performance
Periodo de tiempo: Day 1, day 9, day 10 and day11
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Countermovement jump and drop jump performance will be tested using an optical measurement system consisting of a transmitting and receiving bar
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Day 1, day 9, day 10 and day11
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|
Change in repeated sprint ability
Periodo de tiempo: Day 1, day 9, day 10 and day 11
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Repeated sprint ability will be assessed by performing 5x25 m sprints interspersed by a 25-seconds recovery period using infrared photocells
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Day 1, day 9, day 10 and day 11
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|
Change in delayed onset muscle soreness (DOMS)
Periodo de tiempo: Day 1, day 9, day 10 and day 11
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DOMS will be assessed using a 10-scale visual analogue scale
|
Day 1, day 9, day 10 and day 11
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in total distance covered
Periodo de tiempo: Daily throughout the 11-day experimental period
|
Total distance (km) covered during training and match play will be monitored using Global Positioning System (GPS)
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Daily throughout the 11-day experimental period
|
|
Change in internal load
Periodo de tiempo: Daily throughout the 11-day experimental period
|
Heart rate during training sessions and the match will be monitored using heart rate monitors
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Daily throughout the 11-day experimental period
|
|
Change in dietary intake
Periodo de tiempo: Daily throughout the 11-day experimental period
|
Dietary intake will be assessed using diet recalls
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Daily throughout the 11-day experimental period
|
|
Change in time spent in moderate-to-vigorous physical activity
Periodo de tiempo: Daily throughout the 11-day experimental period
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The time (minutes) spent in moderate-to-vigorous physical activity on a daily basis will be monitored using accelerometers
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Daily throughout the 11-day experimental period
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Change in distance covered with high-intensity running
Periodo de tiempo: Daily throughout the 11-day experimental period
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Distance (km) covered with high-intensity running during training and match play will be monitored using Global Positioning System (GPS)
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Daily throughout the 11-day experimental period
|
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Change in distance covered with sprinting
Periodo de tiempo: Daily throughout the 11-day experimental period
|
Distance (km) covered with high-intensity sprinting during training and match play will be monitored using Global Positioning System (GPS)
|
Daily throughout the 11-day experimental period
|
|
Change in accelerations
Periodo de tiempo: Daily throughout the 11-day experimental period
|
The number of accelerations performed during training and match play will be monitored using Global Positioning System (GPS)
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Daily throughout the 11-day experimental period
|
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Change in decelerations
Periodo de tiempo: Daily throughout the 11-day experimental period
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The number of decelerations performed during training and match play will be monitored using Global Positioning System (GPS)
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Daily throughout the 11-day experimental period
|
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Change in total step count
Periodo de tiempo: Daily throughout the 11-day experimental period
|
The total number of steps performed daily will be monitored using accelerometers
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Daily throughout the 11-day experimental period
|
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Change in physical activity-related energy expenditure
Periodo de tiempo: Daily throughout the 11-day experimental period
|
Energy expenditure (kcal) related to habitual physical activity will be assessed using accelerometers
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Daily throughout the 11-day experimental period
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dimitrios Draganidis, PhD, University of Thessaly, Department of Physical Education and Sport Science
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UTH-06/13.02.2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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