SarcopeniamicroGNCT03665051
Electrical Stimulation of Human Myocytes in Microgravity
An observational study of Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Muscle Tissue Biopsy and Maximal Oxygen Consumption (V02max)
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females in the age ranges 20-40 and 60-80 years were recruited. Participants were medically screened to determine good health, weight stable (less than 3kg weight change during the previous 6 months), and without any contraindication to exercise. Approximately equal numbers of men and women were be recruited. Neither race nor ethnicity were exclusions.
Who may be able to join
- Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Participant is 20-40 or 60-80 years of age, inclusive
- Participant BMI <30 kg/m2
- Participant states willingness to follow protocol as described, including the prescribed activity level and completing any forms needed throughout the study.
Who cannot join
- Participant reports a history of type 1 or type 2 Diabetes; or Hgb A1c > 6.5% at screening visit.
- Participant is actively pursuing weight loss and/or lifestyle changes.
- Participant has a history of pressure ulcers.
- Participant has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3 months) pulmonary embolism, or has a positive D-dimer test and lower extremity ultrasound at screening, or a known hypercoagulable condition, or other clotting or bleeding disorders.
- Participant has poorly controlled hypertension or hypotension in the opinion of the study PI or medical investigator (MI).
- Participant has untreated hypothyroidism or hyperthyroidism.
Show all 22Show fewer
- Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
- Participant is currently taking prescription strength anti-inflammatory medication or has taken prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
- Participant has had surgery requiring >2 days of hospitalization in the last 3 weeks prior to screening visit.
- Participant has an active malignancy or autoimmune disease.
- Participant has current significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit.
- Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
- Participant is an amputee and/or has presence of partial or full artificial limb.
- Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening.
- Participant has a history of, or currently has uncontrolled severe diarrhea, nausea or vomiting.
- Participant has an obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as stage III or above gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
- Participant has used tobacco within the last 3 months.
- Participant has a history of drug or alcohol abuse (> 3 drinks per day) within the last 5 years
- Female participant is pregnant, lactating or is within 6 weeks postpartum prior to the screening visit
- Participant has impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
- Participant's triglyceride level is ≥ 250 mg/dl and LDL cholesterol is > 150 mg/dl at screening.
- Participant has a urine albumin-to-creatinine ratio (UACR) ≥300 mg/g at screening in a single urine specimen (per National Kidney Foundation guideline).
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: Electrical Stimulation of Human Myocytes in Microgravity: An In Vitro Model to Evaluate Therapeutics to Counteract Muscle Wasting (microG)
The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.
- Conditions
- Sarcopenia
- Being tested
- Muscle Tissue Biopsy, Maximal Oxygen Consumption (V02max)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Tissue BiopsyProcedure or surgery
A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.
Maximal Oxygen Consumption (V02max)Other
Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Obtain muscle biopsy specimens from young adults (ages 20-40) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures. Receives: Procedure: Muscle Tissue Biopsy; Other: Maximal Oxygen Consumption (V02max) | |
| Older adults | Obtain muscle biopsy specimens from older adults (ages 60-80) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures. Receives: Procedure: Muscle Tissue Biopsy; Other: Maximal Oxygen Consumption (V02max) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle biopsy parameters
Collection of the muscle biopsy parameters (isolated satellite cells), from 9 participants in each of young and old study groups.
Measured: About 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start25 Jan 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Coen, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665051
- Sponsor's protocol ID
- TRIMD 1311789
- Acronym
- microG
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2018
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim TN, Choi KM. Sarcopenia: definition, epidemiology, and pathophysiology. J Bone Metab. 2013 May;20(1):1-10. doi: 10.11005/jbm.2013.20.1.1. Epub 2013 May 13.
PubMed 24524049Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
PubMed 25549588Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
PubMed 9554417Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.
PubMed 14687319Brioche T, Lemoine-Morel S. Oxidative Stress, Sarcopenia, Antioxidant Strategies and Exercise: Molecular Aspects. Curr Pharm Des. 2016;22(18):2664-78. doi: 10.2174/1381612822666160219120531.
PubMed 26891808Fitts RH, Trappe SW, Costill DL, Gallagher PM, Creer AC, Colloton PA, Peters JR, Romatowski JG, Bain JL, Riley DA. Prolonged space flight-induced alterations in the structure and function of human skeletal muscle fibres. J Physiol. 2010 Sep 15;588(Pt 18):3567-92. doi: 10.1113/jphysiol.2010.188508. Epub 2010 Jul 26.
PubMed 20660569Trappe S, Costill D, Gallagher P, Creer A, Peters JR, Evans H, Riley DA, Fitts RH. Exercise in space: human skeletal muscle after 6 months aboard the International Space Station. J Appl Physiol (1985). 2009 Apr;106(4):1159-68. doi: 10.1152/japplphysiol.91578.2008. Epub 2009 Jan 15.
PubMed 19150852Allen DL, Bandstra ER, Harrison BC, Thorng S, Stodieck LS, Kostenuik PJ, Morony S, Lacey DL, Hammond TG, Leinwand LL, Argraves WS, Bateman TA, Barth JL. Effects of spaceflight on murine skeletal muscle gene expression. J Appl Physiol (1985). 2009 Feb;106(2):582-95. doi: 10.1152/japplphysiol.90780.2008. Epub 2008 Dec 12.
PubMed 19074574Vandenburgh H, Chromiak J, Shansky J, Del Tatto M, Lemaire J; New Collective Author. Space travel directly induces skeletal muscle atrophy. FASEB J. 1999 Jun;13(9):1031-8. doi: 10.1096/fasebj.13.9.1031.
PubMed 10336885Higashibata A, Hashizume T, Nemoto K, Higashitani N, Etheridge T, Mori C, Harada S, Sugimoto T, Szewczyk NJ, Baba SA, Mogami Y, Fukui K, Higashitani A. Microgravity elicits reproducible alterations in cytoskeletal and metabolic gene and protein expression in space-flown Caenorhabditis elegans. NPJ Microgravity. 2016 Jan 21;2:15022. doi: 10.1038/npjmgrav.2015.22. eCollection 2016.
PubMed 28725720Aas V, Bakke SS, Feng YZ, Kase ET, Jensen J, Bajpeyi S, Thoresen GH, Rustan AC. Are cultured human myotubes far from home? Cell Tissue Res. 2013 Dec;354(3):671-82. doi: 10.1007/s00441-013-1655-1. Epub 2013 Jun 8.
PubMed 23749200Gaster M, Petersen I, Hojlund K, Poulsen P, Beck-Nielsen H. The diabetic phenotype is conserved in myotubes established from diabetic subjects: evidence for primary defects in glucose transport and glycogen synthase activity. Diabetes. 2002 Apr;51(4):921-7. doi: 10.2337/diabetes.51.4.921.
PubMed 11916908Henry RR, Ciaraldi TP, Abrams-Carter L, Mudaliar S, Park KS, Nikoulina SE. Glycogen synthase activity is reduced in cultured skeletal muscle cells of non-insulin-dependent diabetes mellitus subjects. Biochemical and molecular mechanisms. J Clin Invest. 1996 Sep 1;98(5):1231-6. doi: 10.1172/JCI118906.
PubMed 8787686Thompson DB, Pratley R, Ossowski V. Human primary myoblast cell cultures from non-diabetic insulin resistant subjects retain defects in insulin action. J Clin Invest. 1996 Nov 15;98(10):2346-50. doi: 10.1172/JCI119046.
PubMed 8941652McGregor RA, Poppitt SD, Cameron-Smith D. Role of microRNAs in the age-related changes in skeletal muscle and diet or exercise interventions to promote healthy aging in humans. Ageing Res Rev. 2014 Sep;17:25-33. doi: 10.1016/j.arr.2014.05.001. Epub 2014 May 14.
PubMed 24833328
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation of Human Myocytes in Microgravity: An In Vitro Model to Evaluate Therapeutics to Counteract Muscle Wasting (microG)
- ClinicalTrials.gov ID
- NCT03665051
- Acronym / sponsor ID
- microG / TRIMD 1311789
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Sep 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.
The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Procedure: Muscle Tissue Biopsy, Other: Maximal Oxygen Consumption (V02max)Obtain muscle biopsy specimens from young adults (ages 20-40) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures. |
| Older adults | – | Procedure: Muscle Tissue Biopsy, Other: Maximal Oxygen Consumption (V02max)Obtain muscle biopsy specimens from older adults (ages 60-80) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females in the age ranges 20-40 and 60-80 years were recruited. Participants were medically screened to determine good health, weight stable (less than 3kg weight change during the previous 6 months), and without any contraindication to exercise. Approximately equal numbers of men and women were be recruited. Neither race nor ethnicity were exclusions.
Key inclusion criteria (4 listed)
- Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- Participant is 20-40 or 60-80 years of age, inclusive
- Participant BMI <30 kg/m2
- Participant states willingness to follow protocol as described, including the prescribed activity level and completing any forms needed throughout the study.
Key exclusion criteria (22 listed)
- Participant reports a history of type 1 or type 2 Diabetes; or Hgb A1c > 6.5% at screening visit.
- Participant is actively pursuing weight loss and/or lifestyle changes.
- Participant has a history of pressure ulcers.
- Participant has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3 months) pulmonary embolism, or has a positive D-dimer test and lower extremity ultrasound at screening, or a known hypercoagulable condition, or other clotting or bleeding disorders.
- Participant has poorly controlled hypertension or hypotension in the opinion of the study PI or medical investigator (MI).
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 |
|---|---|---|
| Muscle Tissue BiopsyA biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief. | Procedure or surgery | Older adults, Young adults |
| Maximal Oxygen Consumption (V02max)Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism. | Other | Older adults, Young adults |
Primary outcome
Muscle biopsy parameters
Time frame: About 30 minutes
Collection of the muscle biopsy parameters (isolated satellite cells), from 9 participants in each of young and old study groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 24524049Kim TN, Choi KM. Sarcopenia: definition, epidemiology, and pathophysiology. J Bone Metab. 2013 May;20(1):1-10. doi: 10.11005/jbm.2013.20.1.1. Epub 2013 May 13.
- Background: PubMed 25549588Cohen S, Nathan JA, Goldberg AL. Muscle wasting in disease: molecular mechanisms and promising therapies. Nat Rev Drug Discov. 2015 Jan;14(1):58-74. doi: 10.1038/nrd4467.
- Background: PubMed 9554417Baumgartner RN, Koehler KM, Gallagher D, Romero L, Heymsfield SB, Ross RR, Garry PJ, Lindeman RD. Epidemiology of sarcopenia among the elderly in New Mexico. Am J Epidemiol. 1998 Apr 15;147(8):755-63. doi: 10.1093/oxfordjournals.aje.a009520.
- Background: PubMed 14687319Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.
- Background: PubMed 26891808Brioche T, Lemoine-Morel S. Oxidative Stress, Sarcopenia, Antioxidant Strategies and Exercise: Molecular Aspects. Curr Pharm Des. 2016;22(18):2664-78. doi: 10.2174/1381612822666160219120531.
- Background: PubMed 20660569Fitts RH, Trappe SW, Costill DL, Gallagher PM, Creer AC, Colloton PA, Peters JR, Romatowski JG, Bain JL, Riley DA. Prolonged space flight-induced alterations in the structure and function of human skeletal muscle fibres. J Physiol. 2010 Sep 15;588(Pt 18):3567-92. doi: 10.1113/jphysiol.2010.188508. Epub 2010 Jul 26.
- Background: PubMed 19150852Trappe S, Costill D, Gallagher P, Creer A, Peters JR, Evans H, Riley DA, Fitts RH. Exercise in space: human skeletal muscle after 6 months aboard the International Space Station. J Appl Physiol (1985). 2009 Apr;106(4):1159-68. doi: 10.1152/japplphysiol.91578.2008. Epub 2009 Jan 15.
- Background: PubMed 19074574Allen DL, Bandstra ER, Harrison BC, Thorng S, Stodieck LS, Kostenuik PJ, Morony S, Lacey DL, Hammond TG, Leinwand LL, Argraves WS, Bateman TA, Barth JL. Effects of spaceflight on murine skeletal muscle gene expression. J Appl Physiol (1985). 2009 Feb;106(2):582-95. doi: 10.1152/japplphysiol.90780.2008. Epub 2008 Dec 12.
- Background: PubMed 10336885Vandenburgh H, Chromiak J, Shansky J, Del Tatto M, Lemaire J; New Collective Author. Space travel directly induces skeletal muscle atrophy. FASEB J. 1999 Jun;13(9):1031-8. doi: 10.1096/fasebj.13.9.1031.
- Background: PubMed 28725720Higashibata A, Hashizume T, Nemoto K, Higashitani N, Etheridge T, Mori C, Harada S, Sugimoto T, Szewczyk NJ, Baba SA, Mogami Y, Fukui K, Higashitani A. Microgravity elicits reproducible alterations in cytoskeletal and metabolic gene and protein expression in space-flown Caenorhabditis elegans. NPJ Microgravity. 2016 Jan 21;2:15022. doi: 10.1038/npjmgrav.2015.22. eCollection 2016.
- Background: PubMed 23749200Aas V, Bakke SS, Feng YZ, Kase ET, Jensen J, Bajpeyi S, Thoresen GH, Rustan AC. Are cultured human myotubes far from home? Cell Tissue Res. 2013 Dec;354(3):671-82. doi: 10.1007/s00441-013-1655-1. Epub 2013 Jun 8.
- Background: PubMed 11916908Gaster M, Petersen I, Hojlund K, Poulsen P, Beck-Nielsen H. The diabetic phenotype is conserved in myotubes established from diabetic subjects: evidence for primary defects in glucose transport and glycogen synthase activity. Diabetes. 2002 Apr;51(4):921-7. doi: 10.2337/diabetes.51.4.921.
- Translational Research Institute for Metabolism and DiabetesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Paul Coen, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by AdventHealth Translational Research Institute at 1 site in United States.
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 22 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Muscle biopsy parameters (time frame: About 30 minutes). 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 NCT03665051, which also lists 22 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 11 Jun 2025.