Skeletal Muscle DamageNCT01778309
NAC Supplementation and Skeletal Muscle Performance
A study testing n-acetylcysteine supplementation in people with Skeletal Muscle Damage and Skeletal Muscle Performance, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
In this investigation the investigators utilized NAC administration to foster GSH availability during an 8-day period following eccentric exercise-induced muscle damage in order to test our hypotheses: i) antioxidant supplementation does not disturb performance and adaptations induced by exercise-induced muscle injury… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Damage, Skeletal Muscle Performance, Intgracellular Signaling in Skeletal Muscle
- What is being tested?
- n-acetylcysteine supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to Apr 2012
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- recreationally trained as evidenced by their maximal oxygen consumption levels (VO2max >45 ml/kg/min), b) were engaged in systematic exercise at least three times/week for ≥12 months), c) non-smokers, d) abstained from any vigorous physical activity during the study, e)abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.
Who cannot join
- a known NAC intolerance or allergy, b) a recent febrile illness, c) history of muscle lesion, d) lower limb trauma
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Physical Education & Sport Performance
Komotini, Thrace, 69100
About this study
Official title: Effects of NAC Supplementation on Skeletal Muscle Performance Following Aseptic Injury Induced by Exercise
In this investigation the investigators utilized NAC administration to foster GSH availability during an 8-day period following eccentric exercise-induced muscle damage in order to test our hypotheses: i) antioxidant supplementation does not disturb performance and adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.
Read the detailed description
The major thiol-disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key-regulator of major transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced cellular adaptations.
Our objective was to examine how thiol-based antioxidant supplementation affects skeletal muscle's performance and redox-sensitive signalling during the inflammatory and repair phases associated with exercise-induced micro-trauma.In a double-blind, counterbalanced design, 12 men received placebo (PLA) or N-acetylcysteine (NAC, 20 mg/kg/day) following muscle-damaging exercise (300 eccentric contractions). In each trial, muscle performance was measured at baseline, post-exercise, 2h post-exercise and daily for 8 consecutive days. Muscle biopsies from vastus lateralis and blood samples were collected pre-exercise and 2h, 2d, and 8d post-exercise.
- Conditions
- Skeletal Muscle Damage, Skeletal Muscle Performance, Intgracellular Signaling in Skeletal Muscle, Inflammatory Status
- Being tested
- n-acetylcysteine supplementation
- Keywords
- aseptic inflammation, skeletal muscle function, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-acetylcysteine supplementationDietary supplement
Also called Exercise-induced skeletal muscle damage
n-acetylcysteine administration: 20 mg//kg/day, orally, daily for eight days following exercise
placebo administration: 500 mL orally, daily for eight days following exercise
| Study group | Role | What they receive |
|---|---|---|
| n-acetylcysteine/placebo supplementation | Experimental | n-acetylcysteine supplementation, orally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise placebo, orally in three daily dosages, content: 500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. Receives: Dietary Supplement: n-acetylcysteine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reduced glutathione in blood
Concentration of reduced glutathione in red blood cells
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in reduced glutathione in muscle
concentration of reduced glutathione in quadriceps skeletal muscle group
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in protein carbonyls in red blood cells and serum
concentration of protein carbonyls
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in protein carbonyls in muscle
protein carbonyl concentration in vastus lateralis skeletal muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in thiobarbituric acid reactive substances in red blood cells and serum
thiobarbituric acid reactive substances concentration in serum and red blood cells
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in thiobarbituric acid reactive substances in muscle
thiobarbituric acid reactive substances concentration in vastus lateralis skeletal muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in oxidized glutathione in red blood cells and blood
Concentration of oxidized glutathione in red blood cells and whole blood
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in total antioxidant capacity in serum
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in oxidized glutathione in muscle
concentration of oxidized glutathione in vastus lateralis skeletal muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in catalase activity in red blood cells and serum
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in glutathione peroxidase activity in red blood cells
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in creatine kinase activity in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in C-reactive protein in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in macrophage infiltration in muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in white blood cell count in blood
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in neutrophil count in blood
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in fatty acid binding protein in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in cortisol concentration in blood
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in testosterone concentration in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in cytokine concentration in plasma
Measurement of IL-1β, IL-4, IL-6, TNF-α, IL-8, IL-10, IL-12p70 concentrations in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in adhesion molecule concentration in blood
Measurement of ICAM-1, VCAM-1, sP-selectin, sE-selectin concentrations in plasma
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in intracellular signalling proteins in muscle
Measurement of phosphorylation levels of protein kinase B (Akt), mammalian target of rapamycin (mTOR), serine/threonine kinase (p70S6K), ribosomal protein S6 (rpS6), nuclear factor κB (NFκB), serine⁄threonine mitogen activated protein kinase (p38-MAPK) in vastus lateralis muscle.
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in myogenic determination factor (MyoD) protein levels in muscle
MyoD expression in vastus lateralis muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in tumor necrosis factor α in muscle
Protein levels of TNF-α in vastus lateralis muscle
Measured: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Secondary outcomes (5)
Change in muscle function of knee extensor and flexor muscle
assessment of muscle peak and mean torque of knee extensors and flexors on an isokinetic dynamometer at 0, 90 and 180 degrees/sec
Measured: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Body composition
Assessment of percent (%) lean body mass.
Measured: One day before exercise
Maximal aerobic capacity
Assessment of maximal oxygen consumption, an indice of cardiovascular conditioning
Measured: One day before exercise
Change in profile of dietary intake
Assessment of dietary intake with emphasis on antioxidant element intake
Measured: one hour before exercise, daily for 8 days post-exercise
Change in side effect occurence
The prevalence of potential side-effects (such as headaches or abdominal pain or any other discomfort) was monitored using a subjective 0-10 side-effects scale on a daily bases by an unblinded investigator (for ethical reasons).
Measured: one hour before exercise, daily for 8 days post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis G. Fatouros, Democritus University of Thrace
- Investigators
- Ioannis F Fatouros, Ph.D., Principal investigator, Democritus University of Thrace, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778309
- Sponsor's protocol ID
- NACEXERCISE2011
- Other IDs
- CE-80739
- Status last verified
- Jan 2013
- First submitted
- 21 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michailidis Y, Karagounis LG, Terzis G, Jamurtas AZ, Spengos K, Tsoukas D, Chatzinikolaou A, Mandalidis D, Stefanetti RJ, Papassotiriou I, Athanasopoulos S, Hawley JA, Russell AP, Fatouros IG. Thiol-based antioxidant supplementation alters human skeletal muscle signaling and attenuates its inflammatory response and recovery after intense eccentric exercise. Am J Clin Nutr. 2013 Jul;98(1):233-45. doi: 10.3945/ajcn.112.049163. Epub 2013 May 29.
PubMed 23719546
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NAC Supplementation on Skeletal Muscle Performance Following Aseptic Injury Induced by Exercise
- ClinicalTrials.gov ID
- NCT01778309
- Acronym / sponsor ID
- NACEXERCISE2011
- Conditions
- Skeletal Muscle Damage, Skeletal Muscle Performance, Intgracellular Signaling in Skeletal Muscle, Inflammatory Status
- Keywords
- aseptic inflammation, skeletal muscle function, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Jan 2013 (estimated)
- 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 administration to foster GSH availability during an 8-day period following eccentric exercise-induced muscle damage in order to test our hypotheses: i) antioxidant supplementation does not disturb performance and adaptations induced by exercise-induced muscle injury and ii) redox status perturbations in skeletal muscle are pivotal for the regulation of muscle' inflammatory response and repair.
Detailed description
The major thiol-disulfide couple of reduced (GSH) and oxidized glutathione (GSSG) is a key-regulator of major transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced cellular adaptations.
Our objective was to examine how thiol-based antioxidant supplementation affects skeletal muscle's performance and redox-sensitive signalling during the inflammatory and repair phases associated with exercise-induced micro-trauma.In a double-blind, counterbalanced design, 12 men received placebo (PLA) or N-acetylcysteine (NAC, 20 mg/kg/day) following muscle-damaging exercise (300 eccentric contractions). In each trial, muscle performance was measured at baseline, post-exercise, 2h post-exercise and daily for 8 consecutive days. Muscle biopsies from vastus lateralis and blood samples were collected pre-exercise and 2h, 2d, and 8d post-exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| n-acetylcysteine/placebo supplementation | Experimental | Dietary Supplement: n-acetylcysteine supplementationn-acetylcysteine supplementation, orally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise placebo, orally in three daily dosages, content: 500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- recreationally trained as evidenced by their maximal oxygen consumption levels (VO2max >45 ml/kg/min), b) were engaged in systematic exercise at least three times/week for ≥12 months), c) non-smokers, d) abstained from any vigorous physical activity during the study, e)abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study.
Key exclusion criteria (1 listed)
- a known NAC intolerance or allergy, b) a recent febrile illness, c) history of muscle lesion, d) lower limb trauma
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-acetylcysteine supplementationAlso: Exercise-induced skeletal muscle damagen-acetylcysteine administration: 20 mg//kg/day, orally, daily for eight days following exercise placebo administration: 500 mL orally, daily for eight days following exercise | Dietary supplement | n-acetylcysteine/placebo supplementation |
Primary outcome
Change in reduced glutathione in blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Concentration of reduced glutathione in red blood cells
Change in reduced glutathione in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
concentration of reduced glutathione in quadriceps skeletal muscle group
Change in protein carbonyls in red blood cells and serum
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
concentration of protein carbonyls
Change in protein carbonyls in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
protein carbonyl concentration in vastus lateralis skeletal muscle
Change in thiobarbituric acid reactive substances in red blood cells and serum
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
thiobarbituric acid reactive substances concentration in serum and red blood cells
Change in thiobarbituric acid reactive substances in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
thiobarbituric acid reactive substances concentration in vastus lateralis skeletal muscle
Change in oxidized glutathione in red blood cells and blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Concentration of oxidized glutathione in red blood cells and whole blood
Change in total antioxidant capacity in serum
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in oxidized glutathione in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
concentration of oxidized glutathione in vastus lateralis skeletal muscle
Change in catalase activity in red blood cells and serum
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in glutathione peroxidase activity in red blood cells
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in creatine kinase activity in plasma
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in C-reactive protein in plasma
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in macrophage infiltration in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Change in white blood cell count in blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in neutrophil count in blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in fatty acid binding protein in plasma
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in cortisol concentration in blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in testosterone concentration in plasma
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Change in cytokine concentration in plasma
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Measurement of IL-1β, IL-4, IL-6, TNF-α, IL-8, IL-10, IL-12p70 concentrations in plasma
Change in adhesion molecule concentration in blood
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Measurement of ICAM-1, VCAM-1, sP-selectin, sE-selectin concentrations in plasma
Change in intracellular signalling proteins in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Measurement of phosphorylation levels of protein kinase B (Akt), mammalian target of rapamycin (mTOR), serine/threonine kinase (p70S6K), ribosomal protein S6 (rpS6), nuclear factor κB (NFκB), serine⁄threonine mitogen activated protein kinase (p38-MAPK) in vastus lateralis muscle.
Change in myogenic determination factor (MyoD) protein levels in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
MyoD expression in vastus lateralis muscle
Change in tumor necrosis factor α in muscle
Time frame: one hour before exercise, 2 hours post-exercise, 2 days post-exercise, 8 days post-exercise
Protein levels of TNF-α in vastus lateralis muscle
5 secondary outcomes
Change in muscle function of knee extensor and flexor muscle
Time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise
Body composition
Time frame: One day before exercise
Maximal aerobic capacity
Time frame: One day before exercise
Change in profile of dietary intake
Time frame: one hour before exercise, daily for 8 days post-exercise
Change in side effect occurence
Time frame: one hour before exercise, daily for 8 days post-exercise
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 29 Jan 2013.
- Derived from this study: PubMed 23719546Michailidis Y, Karagounis LG, Terzis G, Jamurtas AZ, Spengos K, Tsoukas D, Chatzinikolaou A, Mandalidis D, Stefanetti RJ, Papassotiriou I, Athanasopoulos S, Hawley JA, Russell AP, Fatouros IG. Thiol-based antioxidant supplementation alters human skeletal muscle signaling and attenuates its inflammatory response and recovery after intense eccentric exercise. Am J Clin Nutr. 2013 Jul;98(1):233-45. doi: 10.3945/ajcn.112.049163. Epub 2013 May 29.
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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 F Fatouros, Ph.D. principal investigator
Democritus University of Thrace, Greece
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 supplementation in people with Skeletal Muscle Damage and Skeletal Muscle Performance, run by Democritus University of Thrace 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 1 inclusion and 1 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 29 Jan 2013. 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 reduced glutathione in blood (time frame: one hour before exercise, 5 minutes post-exercise, 2 hours post-exercise, daily for 8 days post-exercise). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01778309, which also lists 1 linked publication.
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 29 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.