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临床试验/NCT07690124
NCT07690124尚未招募不适用

Pharmacodynamics & Pharmacokinetics Study of S-Acetyl Glutathione in Highly Trained Soccer Players

University of Thessaly1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Change in creatine kinase levels

研究概览

简要总结

Soccer players display elevated inflammatory and oxidative stress markers combined with reduced soccer specific performance over a 72-hour period. However, in modern soccer, players participate very often in 2 or 3 matches within a week, with a recovery period of 72 hours between successive matches, that is insufficient to restore skeletal muscle homeostasis and performance. Of note, reduced glutathione (GSH) levels, a tripeptide consisting of the amino acids cysteine, glycine and glutamic acid, are substantially reduced during the 72-hour recovery period after a match because of the trauma-related acute inflammatory and oxidative stress response. GSH availability is a crucial regulator of cellular redox status, affecting numerous intracellular and physiological processes such as redox signalling, immunoregulation and muscle metabolism. Indeed, enhanced GSH availability following muscle damaging exercise has been shown to be beneficial for skeletal muscle and performance recovery by mitigating the inflammatory and oxidative stress response. Thus, the enhancement of GSH availability through dietary interventions would be a promising strategy to accelerate skeletal muscle and performance recovery following a soccer game. S-Acetyl Glutathione (SAG) is a glutathione precursor with enhanced absorption kinetics due to chemical S-acetylation of the thiol group on the cysteinyl amino acid of GSH and oral administration of SAG has been shown to be more effective in restoring intracellular glutathione levels compared to oral glutathione. The aim of this study is to (i) perform a pharmacokinetic assessment of 200 mg/day vs 500 mg/day of SAG during a 7-day supplementation period (pre-loading) and (ii) to establish the pharmacodynamic effect of the two dosages at 24, 48 and 72h following a 90-minute official soccer match.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • musculoskeletal injury
  • consumption of medication and performance-enhancing supplements
  • illness during the course of the study
  • loss of follow-up measurements

结局指标

主要结局

Change in creatine kinase levels

时间窗: Day 1, day 7, day 9, day 10 and day 11

Creatine kinase concentration will be measured in serum using a Clinical Chemistry Analyzer

Change in myoglobin levels

时间窗: Day 1, day 7, day 9, day 10 and day 11

Myoglobin concentration will be measured in serum using a Clinical Chemistry Analyzer

Change in reduced glutathione

时间窗: 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

Change in oxidized glutathione

时间窗: 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

Change in glutathione reductase activity

时间窗: 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

Change in glutathione peroxidase activity

时间窗: 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

Change in catalase activity

时间窗: 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

Change in superoxide dismutase activity

时间窗: 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

Change in maximal voluntary isometric contraction

时间窗: 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

Change in maximal peak torque

时间窗: 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

Change in jumping performance

时间窗: 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

Change in repeated sprint ability

时间窗: 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

Change in delayed onset muscle soreness (DOMS)

时间窗: Day 1, day 9, day 10 and day 11

DOMS will be assessed using a 10-scale visual analogue scale

次要结局

  • Change in total distance covered(Daily throughout the 11-day experimental period)
  • Change in internal load(Daily throughout the 11-day experimental period)
  • Change in dietary intake(Daily throughout the 11-day experimental period)
  • Change in time spent in moderate-to-vigorous physical activity(Daily throughout the 11-day experimental period)
  • Change in distance covered with high-intensity running(Daily throughout the 11-day experimental period)
  • Change in distance covered with sprinting(Daily throughout the 11-day experimental period)
  • Change in accelerations(Daily throughout the 11-day experimental period)
  • Change in decelerations(Daily throughout the 11-day experimental period)
  • Change in total step count(Daily throughout the 11-day experimental period)
  • Change in physical activity-related energy expenditure(Daily throughout the 11-day experimental period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Draganidis

Assistant Professor

University of Thessaly

研究点 (1)

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