Skeletal Muscle DamageNCT04523675
NAC Supplementation and Soccer Specific Performance
A study testing N-acetylcysteine in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
Trial summary
In this investigation the investigators utilized NAC supplementation to boost GSH availability during an one-week-microcycle consisting of three soccer games, in order to test the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance and physiological stress variables following… Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- A known NAC intolerance or allergy
- A recent febrile illness
- History of muscle lesion
- Lower limb trauma
- Metabolic diseases
Trial locations and contacts
1 site in 1 country.
Greece1 site
Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly
Trikala, 42100
About this study
Official title: Effects of NAC Supplementation on Immune Function, Inflammatory and Performance Responses of Elite Soccer Players Participated in Three Repetitive Games.
In this investigation the investigators utilized NAC supplementation to boost GSH availability during an one-week-microcycle consisting of three soccer games, in order to test the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance and physiological stress variables following multiple match-plays and ii) redox status perturbations are critical in regulating the inflammatory response and repair in skeletal muscle, following repetitive exercise-induced muscle injuries.
Read the 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.
- Conditions
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance, Antioxidant Status
- Being tested
- N-acetylcysteine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDietary supplement
Also called NAC
Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| EXP-NAC | Experimental | 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. Receives: Dietary Supplement: N-acetylcysteine |
| EXP-Pla | Experimental | 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. Receives: Dietary Supplement: Placebo |
| CON-NAC | Active comparator | Participated in daily training sessions only and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days. Receives: Dietary Supplement: N-acetylcysteine |
| CON-Pla | Active comparator | Participated in daily training sessions only and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total antioxidant capacity in serum
Measured: At baseline and daily throughout the study, up to 11 days
Change in protein carbonyls in serum
Measured: At baseline and daily throughout the study, up to 11 days
Change in thiobarbituric acid reactive substances in serum
Measured: At baseline and daily throughout the study, up to 11 days
Change in reduced glutathione in red blood cells
Measured: At baseline and daily throughout the study, up to 11 days
Change in oxidized glutathione in red blood cells
Measured: At baseline and daily throughout the study, up to 11 days
Change in creatine kinase in activity in plasma
Measured: At baseline and daily throughout the study, up to 11 days
Change in white blood cell count in blood
Measured: At baseline and daily throughout the study, up to 11 days
Change in repeated sprint ability
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.
Measured: At baseline and daily throughout the study, up to 11 days
Change in high intensity running during the game
High intensity running (i.e. > 14km/h) during the games was monitored by utilizing high time-resolution GPS devices.
Measured: During games 1, 2 and 3
Secondary outcomes (2)
Change in blood lactate concentration during the game
Measured: During games 1, 2 and 3
Change in average heart rate during the game
Measured: During games 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study startApr 2016
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, University of Thessaly
- Investigators
- IOANNIS G FATOUROS, Ph.D., Principal investigator, UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523675
- Sponsor's protocol ID
- NAC-SOCCER-2016
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NAC Supplementation on Immune Function, Inflammatory and Performance Responses of Elite Soccer Players Participated in Three Repetitive Games.
- ClinicalTrials.gov ID
- NCT04523675
- Acronym / sponsor ID
- NAC-SOCCER-2016
- Conditions
- Skeletal Muscle Damage, Exercise-induced Aseptic Inflammation, Skeletal Muscle Performance, Antioxidant Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this investigation the investigators utilized NAC supplementation to boost GSH availability during an one-week-microcycle consisting of three soccer games, in order to test the hypotheses that: i) antioxidant supplementation may enhance the recovery of performance and physiological stress variables following multiple match-plays and ii) redox status perturbations are critical in regulating the inflammatory response and repair in skeletal muscle, following repetitive exercise-induced muscle injuries.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EXP-NAC | Experimental | Dietary Supplement: N-acetylcysteineParticipated 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. |
| EXP-Pla | Experimental | Dietary Supplement: PlaceboParticipated in daily training sessions and three games, and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days. |
| CON-NAC | Active comparator | Dietary Supplement: N-acetylcysteineParticipated in daily training sessions only and supplemented daily with N-acetylcysteine, orally in three daily dosages (morning-midday-evening),for seven consecutive days. |
| CON-Pla | Active comparator | Dietary Supplement: PlaceboParticipated in daily training sessions only and supplemented daily with Placebo, orally in three daily dosages (morning-midday-evening), for seven consecutive days. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- A known NAC intolerance or allergy
- A recent febrile illness
- History of muscle lesion
- Lower limb trauma
- Metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: NACOrally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days. | Dietary supplement | CON-NAC, EXP-NAC |
| Placebo500 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. | Dietary supplement | CON-Pla, EXP-Pla |
Primary outcome
Change in total antioxidant capacity in serum
Time frame: At baseline and daily throughout the study, up to 11 days
Change in protein carbonyls in serum
Time frame: At baseline and daily throughout the study, up to 11 days
Change in thiobarbituric acid reactive substances in serum
Time frame: At baseline and daily throughout the study, up to 11 days
Change in reduced glutathione in red blood cells
Time frame: At baseline and daily throughout the study, up to 11 days
Change in oxidized glutathione in red blood cells
Time frame: At baseline and daily throughout the study, up to 11 days
Change in creatine kinase in activity in plasma
Time frame: At baseline and daily throughout the study, up to 11 days
Change in white blood cell count in blood
Time frame: At baseline and daily throughout the study, up to 11 days
Change in repeated sprint ability
Time frame: At baseline and daily throughout the study, up to 11 days
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.
Change in high intensity running during the game
Time frame: During games 1, 2 and 3
High intensity running (i.e. > 14km/h) during the games was monitored by utilizing high time-resolution GPS devices.
2 secondary outcomes
Change in blood lactate concentration during the game
Time frame: During games 1, 2 and 3
Change in average heart rate during the game
Time frame: During games 1, 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IOANNIS G FATOUROS, Ph.D. principal investigator
UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine in people with Skeletal Muscle Damage and Exercise-induced Aseptic Inflammation, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total antioxidant capacity in serum (time frame: At baseline and daily throughout the study, up to 11 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.