SarcopeniaHMB-SARCNCT06801808
HMB Supplementation and Motor Performance in Sarcopenic Patiens
A study testing Myosave in people with Sarcopenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Aging is often accompanied by the reduction and weakening of muscle mass, a condition defined as sarcopenia. According to the most recent criteria from the European Working Group on Sarcopenia in Older People, sarcopenia is considered probable when low muscle strength is documented in the patient. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Myosave
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 99 years;
- Diagnosis of sarcopenia according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP) (Cruz-Jentoft et al., 2018; Kirk et al., 2024), specifically:
- Reduced muscle mass, assessed through bioelectrical impedance analysis (Skeletal Mass Index/height value of ≤ 7.0 kg/m² for men and ≤ 5.5 kg/m² for women);
- Reduced muscle strength, assessed through the Hand Grip Strength Test (value < 27 kg for men and < 16 kg for women);
- Reduced physical performance, assessed through gait speed (≤ 0.8 m/s in the 4-meter walking test) and the Short Physical Performance Battery (score ≤ 8).
- Cognitive abilities sufficient to follow simple instructions and understand the physiotherapist's guidance (assessed using the Mini Mental State Examination, with a corrected score between 22 and 27).
Show all 9Show fewer
- Ability to walk independently or with minimal assistance;
- A history of bed rest lasting at least 5 days;
- Ability to understand and sign the informed consent form.
Who cannot join
- Presence of a known or suspected allergy/intolerance to one or more ingredients of Myosave;
- Presence of kidney or liver diseases;
- Use of anticoagulant or antiplatelet drugs;
- Presence of uncontrolled hypertension or diabetes;
- Oncological diseases, orthopedic or postural issues, presence of plantar ulcers;
- Partial or total amputation of foot segments;
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
Silvia Giovannini, MD, phD, +390630154382, silvia.giovannini@policlinicogemelli.it
Letizia Castelli, MS, +390630154382, letizia.castelli@policlinicogemelli.it
About this study
Official title: Evaluation of HMB Supplementation on Motor Performance in Sarcopenic Patients
Aging is often accompanied by the reduction and weakening of muscle mass, a condition defined as sarcopenia. According to the most recent criteria from the European Working Group on Sarcopenia in Older People, sarcopenia is considered probable when low muscle strength is documented in the patient. The diagnosis of sarcopenia is then confirmed by the presence of reduced muscle mass quantity or quality; it is classified as severe when low muscle strength, reduced muscle quantity and quality, and poor physical performance are all present. According to a recent systematic review of 130 studies, sarcopenia is estimated to affect 10-16% of older adults worldwide. Low muscle strength and rapid atrophy may also result from prolonged immobility, which is an undesirable consequence of hospitalization after illness or injury.
Approximately 65% of elderly patients experience reduced ambulatory function due to hospitalization, and between 30% and 55% report a decline in daily living activities. It has been reported that healthy older adults lose 1 kg (approximately 6%) of lean tissue in the lower limbs after 10 days of bed rest, with a corresponding 16% decline in isokinetic strength of the knee extensors. Muscle atrophy during bed rest is primarily attributed to a marked decrease in skeletal muscle protein synthesis rates, although an accelerated rate of muscle protein degradation compared to synthesis cannot be ruled out. The onset of sarcopenia is further promoted by inflammation, immunosenescence, anabolic resistance, and increased oxidative stress.
Since proper diet, physical activity, and supplementation are currently considered the fundamental pillars for the treatment and prevention of sarcopenia, the identification of a specific food for special medical purposes (AFMS) capable of slowing the progression of sarcopenia is extremely important. Treating sarcopenia also means preventing the associated negative outcomes, including lower overall and progression-free survival rates, postoperative complications, extended hospital stays in patients with various medical conditions, as well as falls and fractures, metabolic disorders, cognitive decline, and mortality in the general population.
Read the detailed description
Myosave® is an AMFS formulated with a specific blend of β-hydroxy-β-methylbutyrate (HMB), sucrosomial® magnesium, sucrosomial® iron, sucrosomial® vitamin D3, sucrosomial® chromium, and amino acids, for the dietary management of sarcopenia and other conditions characterized by muscle mass loss. HMB is a metabolite of leucine that has an anabolic effect on muscles when taken in combination with physical exercise . In healthy older adults engaging in physical activity, HMB (3 g/day) consumed for 8 weeks tended to increase lean mass gain and significantly improved the percentage of body fat loss compared to the placebo group. Furthermore, daily supplementation with HMB (plus arginine and lysine) in older women over 12 weeks significantly improved function and strength. It therefore seems plausible that HMB supplementation could mitigate muscle loss in bedridden elderly patients.
Based on the existing literature, the aim of the study is to evaluate the contribution of Myosave® supplementation to motor performance, cognitive performance, fatigue, and body composition in post-bedrest sarcopenic patients.
Thirty patients of both sexes will be recruiteed, evaluated and treated at the UOC Cardiovascular Internal Medicine and the UOS Post-Acute Rehabilitation units, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome.
Patients will be divided into two groups by randomization, as specified later. One group (G-MyO), in association with the drug therapy already underway, will take 2 sachets of Myosave® per day for 8 weeks, followed by an 8-week observation period. The other group (G-OMy) will undergo an 8-week observation period first, followed by the intake of 2 sachets of Myosave® per day for an additional 8 weeks.
- Conditions
- Sarcopenia
- Being tested
- Myosave
- Keywords
- Sarcopenia, Older adults, Nutrition, HMB
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyosaveDietary supplement
Nutritional supplementation with Myosave
| Study group | Role | What they receive |
|---|---|---|
| G-MyO group | Experimental | Patients in G-MyO group, in addition to the pharmacological therapy routine, will take 2 sachets of Myosave per day for 8 weeks (T0-T2), followed by no product supplementation for the next 8 weeks (T2-T4) Receives: Dietary Supplement: Myosave |
| G-OMy group | Experimental | Patients in G-OMy group, without any changes to their pharmacological routine, will not take the product for the first 8 weeks (T0-T2) and will take 2 sachets of Myosave per day for the next 8 weeks (T2-T4) Receives: Dietary Supplement: Myosave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strenght test (HGST)
HGT is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart.
The average of the three assessments is used as the final value.
Measured: Change from Baseline HGT at 8 and 16 weeks
Secondary outcomes (11)
Short Physical Performance Battery (SPPB)
SPPB is a set of clinical tests used to assess physical performance, particularly lower extremity strenght and functional capacity in older adults. It includes three main components: balance (feet side-by-side, semitandem, and tandem positions), gait speed (time spent to walk 4m), and chair stand tests (five times chair sit-to-stand test). Each test is scored on a scale from 0 to 4, with higher scores indicating better performance. The total score ranges from 0 to 12, with higher scores reflecting better overall physical function.
Measured: Change from Baseline SPPB at 8 and 16 weeks
Time Up&Go Test (TUG)
TUG measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down.
The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling.
The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age.
Measured: Change from Baseline TUG at 8 and 16 weeks
Timed 25 Foot Walk (T25FW)
The T25FW is a performance- based test used to measuere walking speed and mobility. The individuals is asked to walk a distance of 25 feet (approximately 7.62 meters) as quickly and safely as possible, with or without the use of assistive devices. The time taken to complete the walk is recorded, and the test is typically performed twice to ensure accuracy.
Measured: Change from Baseline T25FW at 8 and 16 weeks
Trial Making Test (TMT)
The TMT measueres flexibility of thinking on a visual-motor sequencing task. It consist of two parts, A and B where 25 circles distributed over a sheet paper. In part A, the circles are numbered 1-25, and the patient should draw lines to connect the numbers in ascending order. In part B, the circles include both numbers (1-13) and letters (A-L9: as pattern, but with the added task of alternating between the numebrs and lettes (i.e., 1-A-2-b-3-C, etc.).
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Trail A: Average 29 seconds, deficient> 78 seconds, Rule of Thumb most in 90 seconds. Trial B: Averange 75 seconds, deficient> 273 seconds, Rule of Thumb most in 3 minutes
Measured: Change from Baseline TMT at 8 and 16 weeks
Symbol Digit Modalities Test (SDMT)
The SDMT is a neuropsycological test used to assess cogntive processing speed, attention, and visual-motor coordination. The test involves matching symbols to corresponding numbers based on a key, and participants must quickly and accurately pair the symbols with the correct numbers within a set time limit.
The test evaluates attention, working memory, and mental flexibility. A higher score indicates better cognitive processing speed and accuracy.
Measured: Change from Baseline SDMT at 8 and 16 weeks
Stroop colour Word Test (SCWT)
The SCWT is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. The subject is asked to read the words in the first task, to name colors in the second and third tasks. It is necessary to mark both any mistakes made but also the time spent on each task. The cut-off for the error interference effect is 4.24, while the cut-off for the time interference effect is 36.92.
Measured: Change from Baseline SCWT 8 and 16 weeks
Hospital Anxiety and depression scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a tool used to check for symptoms of anxiety and depression, especially in hospital patients. It has 14 questions, 7 for anxiety and 7 for depression. Each question is scored from 1 to 4.
Measured: Change from Baseline SCWT 8 and 16 weeks
Modified Fatigue Impact scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) is a tool used to assess the impact of fatigue on a person's physical, cognitive, and psychosocial functioning. It consists of 21 items, each scored from 0 (never) to 4 (almost always), with higher scores indicating greater fatigue impact. The scale is divided into three subscales: physical, cognitive, and psychosocial, providing a comprehensive measure of how fatigue affects daily life.
Measured: Change from Baseline SCWT 8 and 16 weeks
EuroQoL-5D (EQ-5D)
EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.
Measured: Change from Baseline SCWT 8 and 16 weeks
Mini Nutritional Assessment- short Form (MNA-SF)
The Mini Nutritional Assessment - Short Form (MNA-SF) is a screening tool used to quickly evaluate the risk of malnutrition in older adults. It consists of 6 questions covering aspects such as weight loss, appetite, mobility, psychological stress, and body mass index (BMI) or calf circumference. Scores range from 0 to 14, with 12-14 indicating normal nutrition, 8-11 at risk of malnutrition, and 0-7 indicating malnutrition.
Measured: Change from Baseline SCWT 8 and 16 weeks
SARC-F
The SARC-F is a simple screening tool used to identify individuals at risk of sarcopenia. It consists of 5 questions assessing strength, assistance with walking, rising from a chair, climbing stairs, and falls. Each item is scored from 0 to 2, with a total score ranging from 0 to 10. A score of 4 or higher suggests a risk of sarcopenia and the need for further assessment.
Measured: Change from Baseline SCWT 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional randomized controlled pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GIOVANNINI SILVIA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Silvia MD Giovannini, phD, Principal investigator, Fondazione Policlinico Iniversitario A.Gemelli, IRCSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801808
- Sponsor's protocol ID
- 0000032/25
- Acronym
- HMB-SARC
- Status last verified
- Apr 2025
- First submitted
- 24 Jan 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of HMB Supplementation on Motor Performance in Sarcopenic Patients
- ClinicalTrials.gov ID
- NCT06801808
- Acronym / sponsor ID
- HMB-SARC / 0000032/25
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Older adults, Nutrition, HMB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jan 2025 (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.
Aging is often accompanied by the reduction and weakening of muscle mass, a condition defined as sarcopenia. According to the most recent criteria from the European Working Group on Sarcopenia in Older People, sarcopenia is considered probable when low muscle strength is documented in the patient. The diagnosis of sarcopenia is then confirmed by the presence of reduced muscle mass quantity or quality; it is classified as severe when low muscle strength, reduced muscle quantity and quality, and poor physical performance are all present. According to a recent systematic review of 130 studies, sarcopenia is estimated to affect 10-16% of older adults worldwide. Low muscle strength and rapid atrophy may also result from prolonged immobility, which is an undesirable consequence of hospitalization after illness or injury.
Approximately 65% of elderly patients experience reduced ambulatory function due to hospitalization, and between 30% and 55% report a decline in daily living activities. It has been reported that healthy older adults lose 1 kg (approximately 6%) of lean tissue in the lower limbs after 10 days of bed rest, with a corresponding 16% decline in isokinetic strength of the knee extensors. Muscle atrophy during bed rest is primarily attributed to a marked decrease in skeletal muscle protein synthesis rates, although an accelerated rate of muscle protein degradation compared to synthesis cannot be ruled out. The onset of sarcopenia is further promoted by inflammation, immunosenescence, anabolic resistance, and increased oxidative stress.
Since proper diet, physical activity, and supplementation are currently considered the fundamental pillars for the treatment and prevention of sarcopenia, the identification of a specific food for special medical purposes (AFMS) capable of slowing the progression of sarcopenia is extremely important. Treating sarcopenia also means preventing the associated negative outcomes, including lower overall and progression-free survival rates, postoperative complications, extended hospital stays in patients with various medical conditions, as well as falls and fractures, metabolic disorders, cognitive decline, and mortality in the general population.
Detailed description
Myosave® is an AMFS formulated with a specific blend of β-hydroxy-β-methylbutyrate (HMB), sucrosomial® magnesium, sucrosomial® iron, sucrosomial® vitamin D3, sucrosomial® chromium, and amino acids, for the dietary management of sarcopenia and other conditions characterized by muscle mass loss. HMB is a metabolite of leucine that has an anabolic effect on muscles when taken in combination with physical exercise . In healthy older adults engaging in physical activity, HMB (3 g/day) consumed for 8 weeks tended to increase lean mass gain and significantly improved the percentage of body fat loss compared to the placebo group. Furthermore, daily supplementation with HMB (plus arginine and lysine) in older women over 12 weeks significantly improved function and strength. It therefore seems plausible that HMB supplementation could mitigate muscle loss in bedridden elderly patients.
Based on the existing literature, the aim of the study is to evaluate the contribution of Myosave® supplementation to motor performance, cognitive performance, fatigue, and body composition in post-bedrest sarcopenic patients.
Thirty patients of both sexes will be recruiteed, evaluated and treated at the UOC Cardiovascular Internal Medicine and the UOS Post-Acute Rehabilitation units, Fondazione Policlinico Universitario A. Gemelli IRCCS of Rome.
Patients will be divided into two groups by randomization, as specified later. One group (G-MyO), in association with the drug therapy already underway, will take 2 sachets of Myosave® per day for 8 weeks, followed by an 8-week observation period. The other group (G-OMy) will undergo an 8-week observation period first, followed by the intake of 2 sachets of Myosave® per day for an additional 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| G-MyO group | Experimental | Dietary Supplement: MyosavePatients in G-MyO group, in addition to the pharmacological therapy routine, will take 2 sachets of Myosave per day for 8 weeks (T0-T2), followed by no product supplementation for the next 8 weeks (T2-T4) |
| G-OMy group | Experimental | Dietary Supplement: MyosavePatients in G-OMy group, without any changes to their pharmacological routine, will not take the product for the first 8 weeks (T0-T2) and will take 2 sachets of Myosave per day for the next 8 weeks (T2-T4) |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 50 and 99 years;
- Diagnosis of sarcopenia according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP) (Cruz-Jentoft et al., 2018; Kirk et al., 2024), specifically:
- Cognitive abilities sufficient to follow simple instructions and understand the physiotherapist's guidance (assessed using the Mini Mental State Examination, with a corrected score between 22 and 27).
- Ability to walk independently or with minimal assistance;
- A history of bed rest lasting at least 5 days;
Key exclusion criteria (7 listed)
- Presence of a known or suspected allergy/intolerance to one or more ingredients of Myosave;
- Presence of kidney or liver diseases;
- Use of anticoagulant or antiplatelet drugs;
- Presence of uncontrolled hypertension or diabetes;
- Oncological diseases, orthopedic or postural issues, presence of plantar ulcers;
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 |
|---|---|---|
| MyosaveNutritional supplementation with Myosave | Dietary supplement | G-MyO group, G-OMy group |
Primary outcome
Hand grip strenght test (HGST)
Time frame: Change from Baseline HGT at 8 and 16 weeks
HGT is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart. The average of the three assessments is used as the final value.
11 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Change from Baseline SPPB at 8 and 16 weeks
Time Up&Go Test (TUG)
Time frame: Change from Baseline TUG at 8 and 16 weeks
Timed 25 Foot Walk (T25FW)
Time frame: Change from Baseline T25FW at 8 and 16 weeks
Trial Making Test (TMT)
Time frame: Change from Baseline TMT at 8 and 16 weeks
Symbol Digit Modalities Test (SDMT)
Time frame: Change from Baseline SDMT at 8 and 16 weeks
Stroop colour Word Test (SCWT)
Time frame: Change from Baseline SCWT 8 and 16 weeks
Hospital Anxiety and depression scale (HADS)
Time frame: Change from Baseline SCWT 8 and 16 weeks
Modified Fatigue Impact scale (MFIS)
Time frame: Change from Baseline SCWT 8 and 16 weeks
EuroQoL-5D (EQ-5D)
Time frame: Change from Baseline SCWT 8 and 16 weeks
Mini Nutritional Assessment- short Form (MNA-SF)
Time frame: Change from Baseline SCWT 8 and 16 weeks
SARC-F
Time frame: Change from Baseline SCWT 8 and 16 weeks
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 14 Jul 2025.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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.
Silvia MD Giovannini, phD principal investigator
Fondazione Policlinico Iniversitario A.Gemelli, IRCSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosave in people with Sarcopenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 14 Jul 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 Italy. 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?
Contact Silvia MD Giovannini, phD (+390630154382, silvia.giovannini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strenght test (HGST) (time frame: Change from Baseline HGT at 8 and 16 weeks). 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 14 Jul 2025.