Treatment of Rheumatologic Patients With Sarcopenia

NCT ID: NCT07135388

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Rheumatic Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rheumatologic sarcopenic patients receiving high protein, high content of HMB oral supplement

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)

Group Type: OTHER

Food for special medical purposes

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Food for special medical purposes

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Michele Barone

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele BARONE, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Polyclinic University Hospital

Bari, BA, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 30513782 (View on PubMed)

Other Identifiers

Study # 6557

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol # 0084855/06/11/2020

Identifier Type: -

Identifier Source: org_study_id