Skeletal Muscle DamageNCT02930031
Redox Status and Immune Function
A study testing n-acetylcysteine in people with Skeletal Muscle Damage and Aseptic Inflammation, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune… 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, Aseptic Inflammation, Skeletal Muscle Function
- 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
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2015to Mar 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally trained (VO2max > 45 ml/kg/min)
- Engaged in regular exercise for ≥3 times/week for > 12 months
- non-smokers
- Abstain from exercise during the course of the two trials
- No consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study.
Who cannot join
- NAC intolerance
- Recent musculoskeletal injuries of the lower limbs
- Febrile illness
- History of muscle lesion.
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of Athens, Medical School, Department of Clinical Therapeutics
Athens, 11527
About this study
Official title: Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation
In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.
Read the detailed description
The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced inflammatory responses.
The objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. Blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.
- Being tested
- n-acetylcysteine, Placebo
- Keywords
- muscle injury, exercise, redox status, immune cells
- 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-acetylcysteineDietary supplement
Also called NAC
20 mg//kg/day, orally, daily for eight days following exercise
PlaceboDietary supplement
500 mL orally, daily for eight days following exercise
| Study group | Role | What they receive |
|---|---|---|
| n-acetylcysteine | Experimental | orally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise Receives: Dietary Supplement: n-acetylcysteine |
| Placebo | Active comparator | 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: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in protein carbonyls in red blood cells
Concentration of protein carbonyls
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in thiobarbituric acid reactive substances in red blood cells
Thiobarbituric acid reactive substances concentration in red blood cells
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in total antioxidant capacity in serum
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in reduced glutathione in blood
Concentration of reduced glutathione in red blood cells
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in oxidized glutathione in blood
Concentration of oxidized glutathione in red blood cells
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in catalase activity in red blood cells
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in creatine kinase activity in serum
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in high sensitivity C-reactive protein in serum
Measured: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
Changes in white blood cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in adhesion molecule concentration in blood
Measurement of soluble vascular cell adhesion molecule-1 (sVCAM-1) and soluble intercellular cell adhesion molecule-1 (sICAM-1) concentrations in plasma
Measured: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
Changes in cytokine concentration in serum
Measurement of interleukin-1β (IL-1β) and interleukin-6 (IL-6)
Measured: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise
Changes in neutrophil count in blood
Cytofluorometric analysis of neutrophil count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in lymphocyte count in blood
Cytofluorometric analysis of lymphocyte count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in monocyte count in blood
Cytofluorometric analysis of monocyte count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in basophil count in blood
Cytofluorometric analysis of baseophil count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in eosinophil count in blood
Cytofluorometric analysis of eosinophil count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in T-helper cell count in blood
Cytofluorometric analysis of T-helper cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in T cytotoxic cell count in blood
Cytofluorometric analysis of T cytotoxic cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in natural killer-T (NK-T) cell count in blood
Cytofluorometric analysis of NK-T cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in 62L macrophage count in blood
Cytofluorometric analysis of 62L macrophage count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in B lympho cell count in blood
Cytofluorometric analysis of B lympho cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in natural killer (NK) cell count in blood
Cytofluorometric analysis of natural killer cell count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in macrophage count in blood
Cytofluorometric analysis of macrophage count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in HLA+/Macr+ macrophage count in blood
Cytofluorometric analysis of HLA+/Macr+ count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in 11B+ macrophage count in blood
Cytofluorometric analysis of 11B+ macrophage count in blood
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Secondary outcomes (5)
Changes in muscle performance
Assessment of maximal knee extensor eccentric peak torque on an isokinetic dynamometer at 60o/s.
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in delayed onset of muscle soreness
Assessment of the delayed onset of muscle soreness by palpation of the vastus lateralis and rectus femoris following a squat motion
Measured: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Maximal aerobic capacity
Assessment of maximal oxygen consumption
Measured: One day before exercise
Body composition
Measurement of body composition by Dual Emission X-ray Absorptiometry (DXA)
Measured: One day before exercise
Changes in dietary intake profile
Assessment of dietary intake with emphasis on antioxidant element intake
Measured: One day before exercise and daily for 8 consecutive 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 posted11 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionMar 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Sakelliou, National and Kapodistrian University of Athens
- Investigators
- Asimina Mitrakou, Associate Prof., Study director, Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930031
- Sponsor's protocol ID
- NACEXERCISE2016
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence of a Redox-dependent Regulation of Immune Responses to Exercise-Induced Inflammation
- ClinicalTrials.gov ID
- NCT02930031
- Acronym / sponsor ID
- NACEXERCISE2016
- Keywords
- muscle injury, exercise, redox status, immune cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Oct 2016 (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 N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.
Detailed description
The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced inflammatory responses.
The objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. Blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-acetylcysteine | Experimental | Dietary Supplement: n-acetylcysteineorally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise |
| Placebo | Active comparator | Dietary Supplement: Placeboorally 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 (5 listed)
- Recreationally trained (VO2max > 45 ml/kg/min)
- Engaged in regular exercise for ≥3 times/week for > 12 months
- non-smokers
- Abstain from exercise during the course of the two trials
- No consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study.
Key exclusion criteria (4 listed)
- NAC intolerance
- Recent musculoskeletal injuries of the lower limbs
- Febrile illness
- History of muscle lesion.
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: NAC20 mg//kg/day, orally, daily for eight days following exercise | Dietary supplement | n-acetylcysteine |
| Placebo500 mL orally, daily for eight days following exercise | Dietary supplement | Placebo |
Primary outcome
Changes in protein carbonyls in red blood cells
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Concentration of protein carbonyls
Changes in thiobarbituric acid reactive substances in red blood cells
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Thiobarbituric acid reactive substances concentration in red blood cells
Changes in total antioxidant capacity in serum
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in reduced glutathione in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Concentration of reduced glutathione in red blood cells
Changes in oxidized glutathione in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Concentration of oxidized glutathione in red blood cells
Changes in catalase activity in red blood cells
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in creatine kinase activity in serum
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in high sensitivity C-reactive protein in serum
Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
Changes in white blood cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in adhesion molecule concentration in blood
Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise
Measurement of soluble vascular cell adhesion molecule-1 (sVCAM-1) and soluble intercellular cell adhesion molecule-1 (sICAM-1) concentrations in plasma
Changes in cytokine concentration in serum
Time frame: Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise
Measurement of interleukin-1β (IL-1β) and interleukin-6 (IL-6)
Changes in neutrophil count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of neutrophil count in blood
Changes in lymphocyte count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of lymphocyte count in blood
Changes in monocyte count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of monocyte count in blood
Changes in basophil count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of baseophil count in blood
Changes in eosinophil count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of eosinophil count in blood
Changes in T-helper cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of T-helper cell count in blood
Changes in T cytotoxic cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of T cytotoxic cell count in blood
Changes in natural killer-T (NK-T) cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of NK-T cell count in blood
Changes in 62L macrophage count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of 62L macrophage count in blood
Changes in B lympho cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of B lympho cell count in blood
Changes in natural killer (NK) cell count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of natural killer cell count in blood
Changes in macrophage count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of macrophage count in blood
Changes in HLA+/Macr+ macrophage count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of HLA+/Macr+ count in blood
Changes in 11B+ macrophage count in blood
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Cytofluorometric analysis of 11B+ macrophage count in blood
5 secondary outcomes
Changes in muscle performance
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Changes in delayed onset of muscle soreness
Time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise
Maximal aerobic capacity
Time frame: One day before exercise
Body composition
Time frame: One day before exercise
Changes in dietary intake profile
Time frame: One day before exercise and daily for 8 consecutive 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 11 Oct 2016.
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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.
Asimina Mitrakou, Associate Prof. study director
Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens
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 Aseptic Inflammation, run by National and Kapodistrian University of Athens 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 5 inclusion and 4 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 11 Oct 2016. 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?
Changes in protein carbonyls in red blood cells (time frame: Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise). The study lists 25 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 11 Oct 2016.