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Treatment of Rheumatologic Patients With Sarcopenia

Treatment of Sarcopenia With Food for Special Medical Purposes in Rheumatologic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07135388
Acronym
REU-SA
Enrollment
15
Registered
2025-08-22
Start date
2021-01-31
Completion date
2024-12-31
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Diseases

Keywords

Sarcopenia, Rheumatologic diseases, Food for Special Medical Purposes

Brief 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). 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.

Interventions

DIETARY_SUPPLEMENTFood for special medical purposes

Oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB)

Sponsors

University of Bari
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients were evaluated before starting the nutritional treatment, and three months later.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle massThe 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 strengthThe interval between the beginning and the end of the single treatment was three monthsMuscle strength was assessed at time zero and after three months of oral supplementation by a dynamometer

Secondary

MeasureTime frameDescription
Assessment of myokines and cytokines blood levelsThe interval between the blood collection performed at the beginning and the end of the single treatment was three monthsBlood was collected at time zero and after three months of oral supplementation to evaluate some myokines (irisin, DBNF, decorin, myostatin) and IL-15.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026