- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07690124
S-Acetyl Glutathione and Performance Recovery in Soccer
Pharmacodynamics & Pharmacokinetics Study of S-Acetyl Glutathione in Highly Trained Soccer Players
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dimitrios Draganidis, PhD
- 전화번호: +30 2431047078
- 이메일: ddraganidis@uth.gr
연구 연락처 백업
- 이름: Athanasios Poulios, PhD
- 전화번호: +30 2431047053
- 이메일: athanpoul@gmail.com
연구 장소
-
-
Karies
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Trikala, Karies, 그리스, 42100
- Department of Physical Education and Sport Science, University of Thessaly
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연락하다:
- Ioannis G Fatouros, PhD
- 전화번호: +30 2431047047
- 이메일: ifatouros@uth.gr
-
연락하다:
- Athanasios Z Jamurtas, PhD
- 전화번호: +30 24310 47054
- 이메일: ajamurt@uth.gr
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in creatine kinase levels
기간: 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
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Change in myoglobin levels
기간: Day 1, day 7, day 9, day 10 and day 11
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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
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Change in reduced glutathione
기간: Day 1, day 7, day 9, day 10 and day 11
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Reduced 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
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Change in oxidized glutathione
기간: Day 1, day 7, day 9, day 10 and day 11
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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
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Change in glutathione reductase activity
기간: 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
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Day 1, day 7, day 9, day 10 and day 11
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Change in glutathione peroxidase activity
기간: 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.
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Change in catalase activity
기간: 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
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Day 1, day 7, day 9, day 10 and day 11
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Change in superoxide dismutase activity
기간: Day 1, day 7, day 9, day 10 and day 11
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Superoxide dismutase 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
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Change in maximal voluntary isometric contraction
기간: Day 1, day 9, day 10 and day 11
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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
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in total distance covered
기간: 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
기간: Daily throughout the 11-day experimental period
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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
기간: Daily throughout the 11-day experimental period
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Dietary intake will be assessed using diet recalls
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Daily throughout the 11-day experimental period
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Change in time spent in moderate-to-vigorous physical activity
기간: 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
기간: 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
기간: 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)
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Daily throughout the 11-day experimental period
|
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Change in accelerations
기간: 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
기간: 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
기간: Daily throughout the 11-day experimental period
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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
기간: Daily throughout the 11-day experimental period
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Energy expenditure (kcal) related to habitual physical activity will be assessed using accelerometers
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Daily throughout the 11-day experimental period
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dimitrios Draganidis, PhD, University of Thessaly, Department of Physical Education and Sport Science
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UTH-06/13.02.2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
운동 유발 염증에 대한 임상 시험
-
Actavis Inc.Watson Laboratories, Inc.완전한세균성 질염 | 평가 및 기록할 징후 및 증상은 다음과 같습니다. | 질 분비물의 색, 냄새 및 일관성 | 외음부 가려움증 및 자극(주관적) 없음, 경미함, 보통 또는 심함 | Vulvovaginal Inflammation (Objective) 부재, 경증, 중등도 또는 중증미국, 도미니카 공화국, 푸에르토 리코
200 mg S-Acetyl Glutathione에 대한 임상 시험
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