Rheumatic DiseasesREU-SANCT07135388
Treatment of Rheumatologic Patients With Sarcopenia
A study testing Food for special medical purposes in people with Rheumatic Diseases, run by University of Bari at 1 site in Italy.
Trial summary
Sarcopenia is defined as a pathological condition related to muscle strength and muscle mass reduction. It is caused by ageing (primary sarcopenia) and diseases associated with systemic inflammation (secondary sarcopenia). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Food for special medical purposes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2021to 31 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Rheumatologic patients able to perform the handgrip test.
Exclusion Criteria: Upper limb arthropathy, chronic kidney disease with an eGFR <50 ml/min, severe congestive heart failure, cancer, decompensated diabetes, severe respiratory failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Sarcopenia With Food for Special Medical Purposes in Rheumatologic Patients
Sarcopenia is defined as a pathological condition related to muscle strength and muscle mass reduction. It is caused by ageing (primary sarcopenia) and diseases associated with systemic inflammation (secondary sarcopenia). Systemic inflammation in rheumatological diseases often leads to physical inactivity, which is the main predictor of sarcopenia in this pathological condition. In these patients, the treatment of sarcopenia must necessarily include an appropriate nutritional approach, and the addition of oral supplements should be considered a complementary approach.
Read the detailed description
Sarcopenia is linked to two distinct pathogenetic mechanisms that often overlap: ageing (primary sarcopenia), and diseases associated with either systemic inflammation or impaired physical activity, or nutritional deficiencies (secondary sarcopenia). Some of the latter mechanisms are intimately connected since the pathway to sarcopenia often begins with a chronic disease that triggers systemic inflammation, leading to physical inactivity, as occurs in rheumatological diseases. Notably, in these patients, the reduction in physical activity leading to sarcopenia represents a prognostic indicator for potential complications and compromised quality of life.
Skeletal muscle trophism is influenced by hormone-like factors known as myokines, which are mainly secreted by muscles themselves, and by cytokines. Among these molecules, irisin, decorin, myonectin, myostatin, and interleukin-15 have been widely studied to develop pharmacological strategies to counteract sarcopenia.
In any case, the treatment of sarcopenia must necessarily include an appropriate nutritional approach that should consider both specific dietary components (dietary patterns) and nutrient intakes (total calories). As a matter of fact, specific dietary patterns are increasingly considered in nutritional studies on sarcopenia.
Currently, it has been observed that "high-quality diets" are associated with better physical functionality and a reduced risk of sarcopenia. However, although some nutrients and dietary patterns seem to have a potential protective effect against sarcopenia, in the presence of pathological conditions, the addition of oral nutritional supplements should offer the opportunity of adding high levels of specific nutritional components which are able to promote muscle trophism.
In this prospective longitudinal study, we evaluated the effect of a specific food for special medical purposes (FSMPs) supplementation on muscle strength, muscle mass, and muscle quality in rheumatologic patients with sarcopenia. In addition, we assessed myokine and cytokine variations in the serum, which are associated with this nutritional approach.
- Conditions
- Rheumatic Diseases
- Being tested
- Food for special medical purposes
- Keywords
- Sarcopenia, Rheumatologic diseases, Food for Special Medical Purposes
- Medical subject headings
- Rheumatic Diseases, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food for special medical purposesDietary supplement
Oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB)
| Study group | Role | What they receive |
|---|---|---|
| Rheumatologic sarcopenic patients receiving high protein, high content of HMB oral supplement | Other | Patients received for three months an oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB) Receives: Dietary Supplement: Food for special medical purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Muscle mass was assessed at time zero and after three months of oral supplementation by bioimpedance analysis
Measured: The interval between the beginning and the end of the single treatment was three months.
Muscle strength
Muscle strength was assessed at time zero and after three months of oral supplementation by a dynamometer
Measured: The interval between the beginning and the end of the single treatment was three months
Secondary outcomes (1)
Assessment of myokines and cytokines blood levels
Blood was collected at time zero and after three months of oral supplementation to evaluate some myokines (irisin, DBNF, decorin, myostatin) and IL-15.
Measured: The interval between the blood collection performed at the beginning and the end of the single treatment was three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start31 Jan 2021
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients were evaluated before starting the nutritional treatment, and three months later.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barone, University of Bari
- Investigators
- Michele BARONE, Associate Professor, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135388
- Sponsor's protocol ID
- Protocol # 0084855/06/11/2020
- Other IDs
- Study # 6557
- Acronym
- REU-SA
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will share data upon formal request by other researchers.
Publications
Barone M, Viggiani MT, Anelli MG, Fanizzi R, Lorusso O, Lopalco G, Cantarini L, Di Leo A, Lapadula G, Iannone F. Sarcopenia in Patients with Rheumatic Diseases: Prevalence and Associated Risk Factors. J Clin Med. 2018 Dec 1;7(12):504. doi: 10.3390/jcm7120504.
PubMed 30513782
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sarcopenia With Food for Special Medical Purposes in Rheumatologic Patients
- ClinicalTrials.gov ID
- NCT07135388
- Acronym / sponsor ID
- REU-SA / Protocol # 0084855/06/11/2020
- Conditions
- Rheumatic Diseases
- Keywords
- Sarcopenia, Rheumatologic diseases, Food for Special Medical Purposes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Aug 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 a pathological condition related to muscle strength and muscle mass reduction. It is caused by ageing (primary sarcopenia) and diseases associated with systemic inflammation (secondary sarcopenia). Systemic inflammation in rheumatological diseases often leads to physical inactivity, which is the main predictor of sarcopenia in this pathological condition. In these patients, the treatment of sarcopenia must necessarily include an appropriate nutritional approach, and the addition of oral supplements should be considered a complementary approach.
Detailed description
Sarcopenia is linked to two distinct pathogenetic mechanisms that often overlap: ageing (primary sarcopenia), and diseases associated with either systemic inflammation or impaired physical activity, or nutritional deficiencies (secondary sarcopenia). Some of the latter mechanisms are intimately connected since the pathway to sarcopenia often begins with a chronic disease that triggers systemic inflammation, leading to physical inactivity, as occurs in rheumatological diseases. Notably, in these patients, the reduction in physical activity leading to sarcopenia represents a prognostic indicator for potential complications and compromised quality of life.
Skeletal muscle trophism is influenced by hormone-like factors known as myokines, which are mainly secreted by muscles themselves, and by cytokines. Among these molecules, irisin, decorin, myonectin, myostatin, and interleukin-15 have been widely studied to develop pharmacological strategies to counteract sarcopenia.
In any case, the treatment of sarcopenia must necessarily include an appropriate nutritional approach that should consider both specific dietary components (dietary patterns) and nutrient intakes (total calories). As a matter of fact, specific dietary patterns are increasingly considered in nutritional studies on sarcopenia.
Currently, it has been observed that "high-quality diets" are associated with better physical functionality and a reduced risk of sarcopenia. However, although some nutrients and dietary patterns seem to have a potential protective effect against sarcopenia, in the presence of pathological conditions, the addition of oral nutritional supplements should offer the opportunity of adding high levels of specific nutritional components which are able to promote muscle trophism.
In this prospective longitudinal study, we evaluated the effect of a specific food for special medical purposes (FSMPs) supplementation on muscle strength, muscle mass, and muscle quality in rheumatologic patients with sarcopenia. In addition, we assessed myokine and cytokine variations in the serum, which are associated with this nutritional approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients were evaluated before starting the nutritional treatment, and three months later.
| Arm | Type | Receives |
|---|---|---|
| Rheumatologic sarcopenic patients receiving high protein, high content of HMB oral supplement | Other | Dietary Supplement: Food for special medical purposesPatients received for three months an oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Food for special medical purposesOral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB) | Dietary supplement | Rheumatologic sarcopenic patients receiving high protein, high content of HMB oral supplement |
Primary outcome
Muscle mass
Time frame: The interval between the beginning and the end of the single treatment was three months.
Muscle mass was assessed at time zero and after three months of oral supplementation by bioimpedance analysis
Muscle strength
Time frame: The interval between the beginning and the end of the single treatment was three months
Muscle strength was assessed at time zero and after three months of oral supplementation by a dynamometer
1 secondary outcome
Assessment of myokines and cytokines blood levels
Time frame: The interval between the blood collection performed at the beginning and the end of the single treatment was three months
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 29 Aug 2025.
- Background: PubMed 30513782Barone M, Viggiani MT, Anelli MG, Fanizzi R, Lorusso O, Lopalco G, Cantarini L, Di Leo A, Lapadula G, Iannone F. Sarcopenia in Patients with Rheumatic Diseases: Prevalence and Associated Risk Factors. J Clin Med. 2018 Dec 1;7(12):504. doi: 10.3390/jcm7120504.
- Individual participant dataSharing planned: Undecided. I will share data upon formal request by other researchers.
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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.
Michele BARONE, Associate Professor principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food for special medical purposes in people with Rheumatic Diseases, run by University of Bari 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?
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 29 Aug 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?
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?
Muscle mass (time frame: The interval between the beginning and the end of the single treatment was three months.). The study lists 2 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 NCT07135388, which also lists 1 linked publication.
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 29 Aug 2025.