Satellite CellsNCT03711838
Redox Regulation of Satellite Cells and Skeletal Muscle Healing
A study testing N-Acetylcysteine in people with Satellite Cells and Redox Status, run by University of Thessaly at 1 site in Greece.
Trial summary
Skeletal muscle stem cells (Satellite cells) are indispensable for muscle growth and remodeling following myofibril damage. Skeletal muscle trauma is present in numerous catabolic conditions, characterized by elevated proteolysis and muscle wasting such as, cancer cachexia and muscular dystrophy, which result in… 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
- Satellite Cells, Redox Status, Exercise-induced Muscle Trauma
- 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
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 22 Jul 2019to 1 Aug 2022
- 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
- No recent history of musculoskeletal injury
- Non-smokers.
- Abstain from any vigorous physical activity during the study
- Abstain from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, NSAIDs and medications before (at least 6 months) and during the study.
Who cannot join
- A known NAC intolerance or allergy
- A recent febrile illness
- A recent history of muscle lesion and/or lower limb trauma
- Presence of metabolic diseases
- Use of anti-inflammatory medication.
- Use of medication interacting with muscle metabolism.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Laboratory of Exercise Biochemistry, Exercise Physiology,and Sports Nutrition, School of Physical Education and Sport Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Official title: The Effect of Redox Potential on the Regulation of Satellite Cells and Skeletal Muscle Healing Following Exercise-Induced Muscle Damage
Skeletal muscle stem cells (Satellite cells) are indispensable for muscle growth and remodeling following myofibril damage. Skeletal muscle trauma is present in numerous catabolic conditions, characterized by elevated proteolysis and muscle wasting such as, cancer cachexia and muscular dystrophy, which result in physical capacity impairment and a deteriorated quality of life. Recent studies performed in animals and cell cultures indicate that the increased levels of inflammation and oxidative stress and the reduction of antioxidant defense may blunt the satellite cells response and myogenic programming during muscle healing. However, evidence regarding the effects of redox status on satellite cells and muscle myogenic potential in humans is lacking. Exercise-induced muscle damage bears striking similarities with the aforementioned conditions, which makes it a valuable tool to investigate the redox-dependent regulation of satellite cells during muscle healing. Thus, the objectives of the present study are to examine the effects of redox status perturbation (via N-acetylcysteine administration) on intracellular pathways responsible for satellite cells responses at rest and following aseptic muscle trauma induced by damaging exercise.
Read the detailed description
A total number of 40-60 young males aged 18-30 will be initially enrolled in the study. Then, participants will be allocated to either a 1) Low glutathione (GSH-low) or a 2) High glutathione (GSH-high) group based on the basal glutathione levels of their vastus lateralis muscle. In a double-blind, crossover, repeated measures design, participants will consume either Placebo (PLA) or N-acetylcysteine (NAC) before (7-day loading phase), on exercise day and for 8 consecutive days following a single bout of intense exercise (300 eccentric contractions at 30 deg/sec in an isokinetic dynamometer). In both conditions, blood samples and muscle biopsies will be collected at baseline, before the exercise protocol and at 2- and 8-days post-exercise. Muscle performance and soreness will also be assessed at the same time points. Before each trial, participants' dietary intake will be analyzed via diet recalls. Physical activity will be analyzed only at baseline via accelerometry. A 4-week washout period will be implemented between trials. Blood samples will be analyzed for inflammation and oxidative stress markers. Muscle samples will be analyzed for satellite cell responses and myogenic potential, protein levels of intracellular signaling proteins, muscle thiols and antioxidant enzyme activity.
- Being tested
- N-Acetylcysteine, Placebo
- Keywords
- Pax7, MyoD, Antioxidants, Myogenic potential, Skeletal muscle healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDietary supplement
N-Acetylcysteine in a powder form diluted in a 250 ml drink containing 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose.
PlaceboDietary supplement
Placebo consisted of 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose.
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine | Experimental | N-Acetylcysteine supplementation: Orally, 40 mg/kg per day in 3 doses (250 ml each) for 7 consecutive days and immediately post-exercise. The remaining 8 days, 40mg/kg per day in 3 doses (250 ml each). Receives: Dietary Supplement: N-Acetylcysteine |
| Placebo | Active comparator | Placebo administration: Orally 750 ml per day in 3 doses (250 ml each) for 7 consecutive days and immediately post-exercise. The remaining 8 days, 750 ml per day in 3 doses (250 ml each). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle satellite cells number (i.e. Pax7+ cells) and activation status (i.e. Pax7+/MyoD+ cells)
Satellite cells number and activation status, will be assessed in muscle via immunohistochemistry.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in muscle myogenic mRNA expression
mRNA expression levels of Myogenic factor 5 (Myf5), myogenin and Myogenic factor 6 (Myf6/MRF4) and myostatin will be assessed in muscle using Real-Time Polymerase Chain Reaction (RT-PCR).
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in muscle inflammatory state
Pro-inflammatory (M1+) and anti-inflammatory (M2+) macrophages will be measured in muscle using immunohistochemistry.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in intracellular antioxidant enzymes in muscle
Protein levels of Glutathione peroxidase 3 (GPx3), Superoxide dismutase 1 (SOD1) and Thioredoxin (Trx1) will be measured using western blotting.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in muscle thiol content
Concentration levels of reduced glutathione (GSH) and oxidized glutathione (GSSG) will be measured spectophotometrically.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in intracellular signaling proteins in muscle
Protein levels of IGF-1, Notch1 and Wnt3 will be measured using western blotting.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in skeletal muscle damage levels
Skeletal muscle damage will be quantified via histochemistry using H\&E staining.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Secondary outcomes (18)
Resting metabolic rate (RMR)
RMR will be assessed after an overnight fast with participants in a supine position following a 15-min stabilization period by taking 30 consecutive 1-min VO2/CO2 measurements using a portable open-circuit indirect calorimeter with a ventilated hood system following a standard calibration protocol.
Measured: At baseline
Body composition
Body composition will be measured using a dual-energy x-ray absorptiometry scanner (DXA).
Measured: At baseline
Maximal oxygen consumption (VO2max)
VO2max will be assessed during continuous incremental running to volitional fatigue on a treadmill with a pulmonary gas exchange system (Oxycon Mobile; Sensor-Medics Corporation).
Measured: At baseline
Isokinetic strength
Maximal knee extensor eccentric peak torque at 60 degrees will be assessed on an isokinetic dynamometer.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in delayed onset of muscle soreness (DOMS)
Muscle soreness will assessed during palpation of the muscle belly and the distal region of relaxed vastus medialis, vastus lateralis and rectus femoris following three repetitions of of a full squat. Subjects will rate their DOMS on a visual analogue scale (0-10).
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Physical activity
Level of habitual physical activity will be assessed using accelerometry (ActiGraph GT3X-BT accelerometer).
Measured: At baseline.
Dietary intake
Daily dietary intake will be assessed using 7-day diet recalls.
Measured: At baseline.
Interleukin-1β (IL-1β) in blood
Concentration of IL-1β will be measured in plasma.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-6 (IL-6) in blood
Concentration of IL-6 will be measured in plasma.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-8 (IL-8) in blood
Concentration of IL-6 will be measured in plasma.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-10 (IL-10) in blood
Concentration of IL-10 will be measured in plasma.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Cortisol in blood
Concentration of cortisol will be measured in serum.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Protein carbonyls (PC)
Concentration of protein carbonyls will be measured in muscle.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Malondialdehyde (MDA)
Concentration of malondialdehyde will be measured in muscle.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Total antioxidant capacity (TAC)
Concentration of TAC will be measured in serum.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Catalase
Concentration of catalase will be measured in red blood cell lysate.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Creatine Kinase (CK)
Concentration of CK will be measured in serum.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
White blood cell count in blood
White blood cell count will be measured in blood. White blood cell count will be measured in blood.
Measured: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start22 Jul 2019
- Primary completion1 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Satellite CellsStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 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
- Konstantinos Papanikolaou, PhD, Principal investigator, University of Thessaly, School of Physical Education & Sport Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711838
- Sponsor's protocol ID
- Satellite Cells - UTH
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2018
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Papanikolaou K, Jamurtas AZ, Poulios A, Tsimeas P, Draganidis D, Margaritelis NV, Baloyiannis I, Papadopoulos C, Sovatzidis A, Deli CK, Rosvoglou A, Georgakouli K, Tzatzakis T, Nikolaidis MG, Fatouros IG. Skeletal muscle and erythrocyte redox status is associated with dietary cysteine intake and physical fitness in healthy young physically active men. Eur J Nutr. 2023 Jun;62(4):1767-1782. doi: 10.1007/s00394-023-03102-2. Epub 2023 Feb 24.
PubMed 36828945Papanikolaou K, Draganidis D, Chatzinikolaou A, Laschou VC, Georgakouli K, Tsimeas P, Batrakoulis A, Deli CK, Jamurtas AZ, Fatouros IG. The redox-dependent regulation of satellite cells following aseptic muscle trauma (SpEED): study protocol for a randomized controlled trial. Trials. 2019 Jul 31;20(1):469. doi: 10.1186/s13063-019-3557-3.
PubMed 31366396
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Redox Potential on the Regulation of Satellite Cells and Skeletal Muscle Healing Following Exercise-Induced Muscle Damage
- ClinicalTrials.gov ID
- NCT03711838
- Acronym / sponsor ID
- Satellite Cells - UTH
- Keywords
- Pax7, MyoD, Antioxidants, Myogenic potential, Skeletal muscle healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 19 Oct 2018 (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.
Skeletal muscle stem cells (Satellite cells) are indispensable for muscle growth and remodeling following myofibril damage. Skeletal muscle trauma is present in numerous catabolic conditions, characterized by elevated proteolysis and muscle wasting such as, cancer cachexia and muscular dystrophy, which result in physical capacity impairment and a deteriorated quality of life. Recent studies performed in animals and cell cultures indicate that the increased levels of inflammation and oxidative stress and the reduction of antioxidant defense may blunt the satellite cells response and myogenic programming during muscle healing. However, evidence regarding the effects of redox status on satellite cells and muscle myogenic potential in humans is lacking. Exercise-induced muscle damage bears striking similarities with the aforementioned conditions, which makes it a valuable tool to investigate the redox-dependent regulation of satellite cells during muscle healing. Thus, the objectives of the present study are to examine the effects of redox status perturbation (via N-acetylcysteine administration) on intracellular pathways responsible for satellite cells responses at rest and following aseptic muscle trauma induced by damaging exercise.
Detailed description
A total number of 40-60 young males aged 18-30 will be initially enrolled in the study. Then, participants will be allocated to either a 1) Low glutathione (GSH-low) or a 2) High glutathione (GSH-high) group based on the basal glutathione levels of their vastus lateralis muscle. In a double-blind, crossover, repeated measures design, participants will consume either Placebo (PLA) or N-acetylcysteine (NAC) before (7-day loading phase), on exercise day and for 8 consecutive days following a single bout of intense exercise (300 eccentric contractions at 30 deg/sec in an isokinetic dynamometer). In both conditions, blood samples and muscle biopsies will be collected at baseline, before the exercise protocol and at 2- and 8-days post-exercise. Muscle performance and soreness will also be assessed at the same time points. Before each trial, participants' dietary intake will be analyzed via diet recalls. Physical activity will be analyzed only at baseline via accelerometry. A 4-week washout period will be implemented between trials. Blood samples will be analyzed for inflammation and oxidative stress markers. Muscle samples will be analyzed for satellite cell responses and myogenic potential, protein levels of intracellular signaling proteins, muscle thiols and antioxidant enzyme activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine | Experimental | Dietary Supplement: N-AcetylcysteineN-Acetylcysteine supplementation: Orally, 40 mg/kg per day in 3 doses (250 ml each) for 7 consecutive days and immediately post-exercise. The remaining 8 days, 40mg/kg per day in 3 doses (250 ml each). |
| Placebo | Active comparator | Dietary Supplement: PlaceboPlacebo administration: Orally 750 ml per day in 3 doses (250 ml each) for 7 consecutive days and immediately post-exercise. The remaining 8 days, 750 ml per day in 3 doses (250 ml each). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No recent history of musculoskeletal injury
- Non-smokers.
- Abstain from any vigorous physical activity during the study
- Abstain from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, NSAIDs and medications before (at least 6 months) and during the study.
Key exclusion criteria (6 listed)
- A known NAC intolerance or allergy
- A recent febrile illness
- A recent history of muscle lesion and/or lower limb trauma
- Presence of metabolic diseases
- Use of anti-inflammatory medication.
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-AcetylcysteineN-Acetylcysteine in a powder form diluted in a 250 ml drink containing 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose. | Dietary supplement | N-Acetylcysteine |
| PlaceboPlacebo consisted of 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose. | Dietary supplement | Placebo |
Primary outcome
Change in muscle satellite cells number (i.e. Pax7+ cells) and activation status (i.e. Pax7+/MyoD+ cells)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Satellite cells number and activation status, will be assessed in muscle via immunohistochemistry.
Change in muscle myogenic mRNA expression
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
mRNA expression levels of Myogenic factor 5 (Myf5), myogenin and Myogenic factor 6 (Myf6/MRF4) and myostatin will be assessed in muscle using Real-Time Polymerase Chain Reaction (RT-PCR).
Change in muscle inflammatory state
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Pro-inflammatory (M1+) and anti-inflammatory (M2+) macrophages will be measured in muscle using immunohistochemistry.
Change in intracellular antioxidant enzymes in muscle
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Protein levels of Glutathione peroxidase 3 (GPx3), Superoxide dismutase 1 (SOD1) and Thioredoxin (Trx1) will be measured using western blotting.
Change in muscle thiol content
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Concentration levels of reduced glutathione (GSH) and oxidized glutathione (GSSG) will be measured spectophotometrically.
Change in intracellular signaling proteins in muscle
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Protein levels of IGF-1, Notch1 and Wnt3 will be measured using western blotting.
Change in skeletal muscle damage levels
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Skeletal muscle damage will be quantified via histochemistry using H\&E staining.
18 secondary outcomes
Resting metabolic rate (RMR)
Time frame: At baseline
Body composition
Time frame: At baseline
Maximal oxygen consumption (VO2max)
Time frame: At baseline
Isokinetic strength
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Change in delayed onset of muscle soreness (DOMS)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Physical activity
Time frame: At baseline.
Dietary intake
Time frame: At baseline.
Interleukin-1β (IL-1β) in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-6 (IL-6) in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-8 (IL-8) in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Interleukin-10 (IL-10) in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Cortisol in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Protein carbonyls (PC)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Malondialdehyde (MDA)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Total antioxidant capacity (TAC)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Catalase
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
Creatine Kinase (CK)
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.
White blood cell count in blood
Time frame: At baseline, before the exercise protocol and at days 2 and 8 following 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 20 Nov 2024.
- Derived from this study: PubMed 36828945Papanikolaou K, Jamurtas AZ, Poulios A, Tsimeas P, Draganidis D, Margaritelis NV, Baloyiannis I, Papadopoulos C, Sovatzidis A, Deli CK, Rosvoglou A, Georgakouli K, Tzatzakis T, Nikolaidis MG, Fatouros IG. Skeletal muscle and erythrocyte redox status is associated with dietary cysteine intake and physical fitness in healthy young physically active men. Eur J Nutr. 2023 Jun;62(4):1767-1782. doi: 10.1007/s00394-023-03102-2. Epub 2023 Feb 24.
- Derived from this study: PubMed 31366396Papanikolaou K, Draganidis D, Chatzinikolaou A, Laschou VC, Georgakouli K, Tsimeas P, Batrakoulis A, Deli CK, Jamurtas AZ, Fatouros IG. The redox-dependent regulation of satellite cells following aseptic muscle trauma (SpEED): study protocol for a randomized controlled trial. Trials. 2019 Jul 31;20(1):469. doi: 10.1186/s13063-019-3557-3.
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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.
Konstantinos Papanikolaou, PhD principal investigator
University of Thessaly, School of Physical Education & Sport Science
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 Satellite Cells and Redox Status, 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 6 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 20 Nov 2024. 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 muscle satellite cells number (i.e. Pax7+ cells) and activation status (i.e. Pax7+/MyoD+ cells) (time frame: At baseline, before the exercise protocol and at days 2 and 8 following exercise.). The study lists 7 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 NCT03711838, which also lists 2 linked publications.
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 20 Nov 2024.