- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07690124
S-Acetyl Glutathione and Performance Recovery in Soccer
Pharmacodynamics & Pharmacokinetics Study of S-Acetyl Glutathione in Highly Trained Soccer Players
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dimitrios Draganidis, PhD
- Telefonní číslo: +30 2431047078
- E-mail: ddraganidis@uth.gr
Studijní záloha kontaktů
- Jméno: Athanasios Poulios, PhD
- Telefonní číslo: +30 2431047053
- E-mail: athanpoul@gmail.com
Studijní místa
-
-
Karies
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Trikala, Karies, Řecko, 42100
- Department of Physical Education and Sport Science, University of Thessaly
-
Kontakt:
- Ioannis G Fatouros, PhD
- Telefonní číslo: +30 2431047047
- E-mail: ifatouros@uth.gr
-
Kontakt:
- Athanasios Z Jamurtas, PhD
- Telefonní číslo: +30 24310 47054
- E-mail: ajamurt@uth.gr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: SAG-200 Trial
Oral administration of S-Acetyl Glutathione (SAG)
|
Participants will be supplemented daily with 200 mg of S-acetyl glutathione, orally, over the 11-day experimental period.
|
|
Experimentální: 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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Komparátor placeba: Placebo Trial
Oral administration of placebo
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Participants will be supplemented daily with placebo, orally, over the 11-day experimental period.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in creatine kinase levels
Časové okno: Day 1, day 7, day 9, day 10 and day 11
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Creatine kinase 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 myoglobin levels
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in glutathione reductase activity
Časové okno: Day 1, day 7, day 9, day 10 and day 11
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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
Časové okno: Day 1, day 7, day 9, day 10 and day 11.
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Glutathione peroxidase activity 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 catalase activity
Časové okno: Day 1, day 7, day 9, day 10 and day 11
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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
Časové okno: 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
Časové okno: 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
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|
Change in maximal peak torque
Časové okno: Day 1, day 9, day 10 and day 11
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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
Časové okno: 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
|
|
Change in repeated sprint ability
Časové okno: Day 1, day 9, day 10 and day 11
|
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)
Časové okno: Day 1, day 9, day 10 and day 11
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DOMS will be assessed using a 10-scale visual analogue scale
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Day 1, day 9, day 10 and day 11
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in total distance covered
Časové okno: Daily throughout the 11-day experimental period
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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
|
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Change in internal load
Časové okno: 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
|
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Change in dietary intake
Časové okno: 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
Časové okno: Daily throughout the 11-day experimental period
|
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
Časové okno: Daily throughout the 11-day experimental period
|
Distance (km) covered with high-intensity running during training and match play will be monitored using Global Positioning System (GPS)
|
Daily throughout the 11-day experimental period
|
|
Change in distance covered with sprinting
Časové okno: 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
Časové okno: Daily throughout the 11-day experimental period
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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
|
|
Change in decelerations
Časové okno: Daily throughout the 11-day experimental period
|
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
|
|
Change in total step count
Časové okno: 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
Časové okno: Daily throughout the 11-day experimental period
|
Energy expenditure (kcal) related to habitual physical activity will be assessed using accelerometers
|
Daily throughout the 11-day experimental period
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dimitrios Draganidis, PhD, University of Thessaly, Department of Physical Education and Sport Science
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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 identifikační čísla studie
- UTH-06/13.02.2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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