SarcopeniaSARCO-BIODYNCT07011030
Diagnosis of Sarcopenia in Older Adults
A study testing Measure of skeletal muscle mass in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Measure of skeletal muscle mass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2025to 4 Dec 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 60 or over already receiving care at the Day Hospital of the Rehabilitation, Independence and Aging Center or the Frailty Platform of the Rehabilitation, Independence and Aging Center.
- Patients affiliated with or covered by a social security system.
- Patients who have signed an informed consent form in advance.
Who cannot join
- Vulnerable persons as defined in Articles L1121-5 to -8
- People with pacemakers, implantable defibrillators, or other electronic medical devices
- Musculoskeletal disorders that prevent bioimpedance measurement in a seated position
- Any condition of fluid retention or dehydration
- Absence of a measurement site (muscle resection or amputation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Use of a Bioimpedance Meter With Integretaed Electrodes and Osteodensitometry for the Diagnosis os Sarcopenia in the Elderly
Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Given the aging of the French population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass.
In its recommendations, French National Authority for Health recommends the use osteodensitometry and bioimpedance analysis (BIA) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. Traditionally, BIA assessment is performed while lying down using adhesive electrodes placed on the hands and feet. The Biody XpertZM3 is a BIA device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. However, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer
- Conditions
- Sarcopenia
- Being tested
- Measure of skeletal muscle mass
- Keywords
- sarcopenia, elderly, bioimpedance analysis, osteodensitometry
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of skeletal muscle massOther
Bioimpedance analysis with integrated electrodes and osteodensitometry examination
| Study group | Role | What they receive |
|---|---|---|
| Skeletal muscle mass measurement | Experimental | Patients will undergo a:
* Bioimpedance analysis with the Biody XpertZM 3 (bioimpedance device with integrated electrodes )
* Osteodensitometer analysis with the SRATOS DR Receives: Other: Measure of skeletal muscle mass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass
Comparison of skeletal muscle mass of the limbs (in kg) obtained by bioimpedance analysis using integrated electrodes and using osteodensitometry
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start23 Sep 2025
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
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 Centre Hospitalier Universitaire de NiceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric CHORIN, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011030
- Sponsor's protocol ID
- 25-PP-04
- Acronym
- SARCO-BIODY
- Status last verified
- Dec 2025
- First submitted
- 30 May 2025
- Last updated
- 16 Dec 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Use of a Bioimpedance Meter With Integretaed Electrodes and Osteodensitometry for the Diagnosis os Sarcopenia in the Elderly
- ClinicalTrials.gov ID
- NCT07011030
- Acronym / sponsor ID
- SARCO-BIODY / 25-PP-04
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, elderly, bioimpedance analysis, osteodensitometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 8 Jun 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.
Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Given the aging of the French population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass.
In its recommendations, French National Authority for Health recommends the use osteodensitometry and bioimpedance analysis (BIA) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. Traditionally, BIA assessment is performed while lying down using adhesive electrodes placed on the hands and feet. The Biody XpertZM3 is a BIA device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. However, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skeletal muscle mass measurement | Experimental | Other: Measure of skeletal muscle massPatients will undergo a: * Bioimpedance analysis with the Biody XpertZM 3 (bioimpedance device with integrated electrodes ) * Osteodensitometer analysis with the SRATOS DR |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women aged 60 or over already receiving care at the Day Hospital of the Rehabilitation, Independence and Aging Center or the Frailty Platform of the Rehabilitation, Independence and Aging Center.
- Patients affiliated with or covered by a social security system.
- Patients who have signed an informed consent form in advance.
Key exclusion criteria (5 listed)
- Vulnerable persons as defined in Articles L1121-5 to -8
- People with pacemakers, implantable defibrillators, or other electronic medical devices
- Musculoskeletal disorders that prevent bioimpedance measurement in a seated position
- Any condition of fluid retention or dehydration
- Absence of a measurement site (muscle resection or amputation)
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 |
|---|---|---|
| Measure of skeletal muscle massBioimpedance analysis with integrated electrodes and osteodensitometry examination | Other | Skeletal muscle mass measurement |
Primary outcome
Appendicular skeletal muscle mass
Time frame: day 0
Comparison of skeletal muscle mass of the limbs (in kg) obtained by bioimpedance analysis using integrated electrodes and using osteodensitometry
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 16 Dec 2025.
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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.
Frédéric CHORIN, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of skeletal muscle mass in people with Sarcopenia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 5 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 16 Dec 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 France. 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?
Appendicular skeletal muscle mass (time frame: day 0). 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 16 Dec 2025.