- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07690124
S-Acetyl Glutathione and Performance Recovery in Soccer
Pharmacodynamics & Pharmacokinetics Study of S-Acetyl Glutathione in Highly Trained Soccer Players
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Dimitrios Draganidis, PhD
- Telefonnummer: +30 2431047078
- E-mail: ddraganidis@uth.gr
Undersøgelse Kontakt Backup
- Navn: Athanasios Poulios, PhD
- Telefonnummer: +30 2431047053
- E-mail: athanpoul@gmail.com
Studiesteder
-
-
Karies
-
Trikala, Karies, Grækenland, 42100
- Department of Physical Education and Sport Science, University of Thessaly
-
Kontakt:
- Ioannis G Fatouros, PhD
- Telefonnummer: +30 2431047047
- E-mail: ifatouros@uth.gr
-
Kontakt:
- Athanasios Z Jamurtas, PhD
- Telefonnummer: +30 24310 47054
- E-mail: ajamurt@uth.gr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: SAG-500 Trial
Oral administration of S-Acetyl Glutathione (SAG)
|
Participants will be supplemented daily with 500 mg of S-acetyl glutathione, orally, over the 11-day experimental period.
|
|
Placebo komparator: Placebo Trial
Oral administration of placebo
|
Participants will be supplemented daily with placebo, orally, over the 11-day experimental period.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in creatine kinase levels
Tidsramme: 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
Tidsramme: Day 1, day 7, day 9, day 10 and day 11
|
Myoglobin concentration will be measured in serum using a Clinical Chemistry Analyzer
|
Day 1, day 7, day 9, day 10 and day 11
|
|
Change in reduced glutathione
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Day 1, day 9, day 10 and day 11
|
|
Change in maximal peak torque
Tidsramme: 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
|
Day 1, day 9, day 10 and day 11
|
|
Change in jumping performance
Tidsramme: Day 1, day 9, day 10 and day11
|
Countermovement jump and drop jump performance will be tested using an optical measurement system consisting of a transmitting and receiving bar
|
Day 1, day 9, day 10 and day11
|
|
Change in repeated sprint ability
Tidsramme: 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
|
Day 1, day 9, day 10 and day 11
|
|
Change in delayed onset muscle soreness (DOMS)
Tidsramme: Day 1, day 9, day 10 and day 11
|
DOMS will be assessed using a 10-scale visual analogue scale
|
Day 1, day 9, day 10 and day 11
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in total distance covered
Tidsramme: Daily throughout the 11-day experimental period
|
Total distance (km) covered during training and match play will be monitored using Global Positioning System (GPS)
|
Daily throughout the 11-day experimental period
|
|
Change in internal load
Tidsramme: Daily throughout the 11-day experimental period
|
Heart rate during training sessions and the match will be monitored using heart rate monitors
|
Daily throughout the 11-day experimental period
|
|
Change in dietary intake
Tidsramme: Daily throughout the 11-day experimental period
|
Dietary intake will be assessed using diet recalls
|
Daily throughout the 11-day experimental period
|
|
Change in time spent in moderate-to-vigorous physical activity
Tidsramme: 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
|
Daily throughout the 11-day experimental period
|
|
Change in distance covered with high-intensity running
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Daily throughout the 11-day experimental period
|
|
Change in decelerations
Tidsramme: 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)
|
Daily throughout the 11-day experimental period
|
|
Change in total step count
Tidsramme: Daily throughout the 11-day experimental period
|
The total number of steps performed daily will be monitored using accelerometers
|
Daily throughout the 11-day experimental period
|
|
Change in physical activity-related energy expenditure
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dimitrios Draganidis, PhD, University of Thessaly, Department of Physical Education and Sport Science
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UTH-06/13.02.2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Træningsinduceret betændelse
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereAfsluttetHemiplegi | Spædbørns udvikling | Constraint Induced Movement TherapyForenede Stater
-
The First Affiliated Hospital with Nanjing Medical...Rekruttering
-
Istanbul Bilgi UniversityTilmelding efter invitationSystemisk inflammation | Bariatrisk kirurgi | Bariatrisk ærmegatrektomi | Diætbetændelsesindeks (DII) | Systemiske inflammationsmarkører | InflammationTyrkiet (Türkiye)
-
Ankara City Hospital BilkentIkke rekrutterer endnuAngiogenese | Healing | Inflammation
-
Center for Research and Innovation Viña Concha...Universidad Católica del MauleIkke rekrutterer endnuInflammatorisk | Antioxidantstatus, inflammation | Inflammation biomarkører | Antioxidant evner | Cardiometabolic sundhedsindikatorerChile
-
BiogenRekrutteringMikrovaskulær inflammationForenede Stater, Østrig, Spanien, Tyskland, Australien, Frankrig, Schweiz, Argentina, Brasilien, Tjekkiet
-
Cornell UniversityPATH; Institut Pasteur de Madagascar; Université d'AntananarivoIkke rekrutterer endnuJernoptagelse | Tarm - Mikrobiota | InflammationMadagaskar
-
University of California, Los AngelesRekrutteringPsykosocial funktion | Stress (psykologi) | InflammationForenede Stater
-
BiogenTilmelding efter invitationAntistof-medieret afvisning | Mikrovaskulær inflammationForenede Stater
-
Elazıg Fethi Sekin Sehir HastanesiAfsluttetSystemisk inflammation | Perkutan nefrolitotomi | AnæstesiteknikkerTyrkiet (Türkiye)
Kliniske forsøg med 200 mg S-Acetyl Glutathione
-
ShionogiAfsluttet
-
Alaunos TherapeuticsAfsluttetAvancerede solide tumorerForenede Stater
-
Yuhan CorporationAfsluttet
-
Mylan Pharmaceuticals IncAfsluttetSund og raskForenede Stater
-
Atabay Kimya Sanayi Ticaret A.S.Novagenix Bioanalytical Drug R&D Center; Farmagen Ar-Ge Biyot. Ltd. StiAfsluttet
-
Novelfarma Ilaç San. ve Tic. Ltd. Sti.Novagenix Bioanalytical Drug R&D Center; Farmagen Ar-Ge Biyot. Ltd. StiAfsluttet
-
Ascletis Pharmaceuticals Co., Ltd.Ascletis Pharmaceuticals Co., Ltd.AfsluttetAvancerede solide tumorerForenede Stater
-
Novartis PharmaceuticalsAfsluttetIkke-småcellet lungekarcinomIndien
-
World Medicine ILAC SAN. ve TIC. A.S.Novagenix Bioanalytical Drug R&D Center; Farmagen Ar-Ge Biyot. Ltd. StiAfsluttet
-
ShionogiAfsluttet