- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523675
NAC Supplementation and Soccer Specific Performance
Effects of NAC Supplementation on Immune Function, Inflammatory and Performance Responses of Elite Soccer Players Participated in Three Repetitive Games.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After exercise-induced muscle microtrauma the thiol/disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key regulator of important transcriptional pathways that control the inflammatory response and recovery of skeletal muscle.
The objective was to examine how thiol-based antioxidant supplementation affects the muscle damage, oxidative stress, inflammatory and immune responses, as well as the level of post-game fatigue and muscle's recovery kinetics in response to three soccer games within a week. Participants were randomly assigned to one of four groups: i) Experimental-NAC [EXP-NAC, N=10, participated in daily training sessions and three games and received NAC (20 mg/kg/day)], ii) Experimental-Placebo (EXP-Pla, N=10, participated in daily training sessions and three games and received Placebo), iii) Control-NAC [CON-NAC, N=10, participated in daily training sessions only and received NAC(20 mg/kg/day)] and iv) Control-Placebo (CON-Pla, N=10, participated in daily training sessions only and received Placebo). Blood samples were collected at baseline, post-games and daily during recovery. Performance was assessed at baseline and daily during recovery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tríkala, Greece, 42100
- Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participation at elite level (top three division leagues) of soccer competition for at least five years
- Abstained from consumption of performance-enhancing supplements, antioxidant supplements and medications (for at least 6 months before and during the study)
- Participation in at least six two-hour training sessions and one match per week
- Non-smokers
Exclusion Criteria:
- A known NAC intolerance or allergy
- A recent febrile illness
- History of muscle lesion
- Lower limb trauma
- Metabolic diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EXP-NAC
Participated in daily training sessions and three games, and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days.
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Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
Other Names:
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Experimental: EXP-Pla
Participated in daily training sessions and three games, and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days.
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500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder.
Orally in three daily dosages (morning-midday-evening), for seven consecutive days.
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Active Comparator: CON-NAC
Participated in daily training sessions only and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days.
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Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
Other Names:
|
Active Comparator: CON-Pla
Participated in daily training sessions only and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days.
|
500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder.
Orally in three daily dosages (morning-midday-evening), for seven consecutive days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in total antioxidant capacity in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in protein carbonyls in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in thiobarbituric acid reactive substances in serum
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
|
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Change in reduced glutathione in red blood cells
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in oxidized glutathione in red blood cells
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in creatine kinase in activity in plasma
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in white blood cell count in blood
Time Frame: At baseline and daily throughout the study, up to 11 days
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At baseline and daily throughout the study, up to 11 days
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Change in repeated sprint ability
Time Frame: At baseline and daily throughout the study, up to 11 days
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Players' repeated sprint ability was assessed via a repeared sprint test.
Each player performed 5 x 30 meters sprints interspersed by 25 seconds of active recovery.
Sprint time was recorded by using infrared photoelectrical gates.
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At baseline and daily throughout the study, up to 11 days
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Change in high intensity running during the game
Time Frame: During games 1, 2 and 3
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High intensity running (i.e.
> 14km/h) during the games was monitored by utilizing high time-resolution GPS devices.
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During games 1, 2 and 3
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood lactate concentration during the game
Time Frame: During games 1, 2 and 3
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During games 1, 2 and 3
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Change in average heart rate during the game
Time Frame: During games 1, 2 and 3
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During games 1, 2 and 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: IOANNIS G FATOUROS, Ph.D., UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAC-SOCCER-2016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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