Treatment of Rheumatologic Patients With Sarcopenia (REU-SA)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic Diseases
• Intervention / Treatment: Dietary supplement: Food for special medical purposes

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • Polyclinic University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Dietary supplement: Food for special medical purposes; Oral supplementation with a protein supplement high in branched-chain amino acids and β-hydroxy-β-methyl-butyrate (HMB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	Muscle mass was assessed at time zero and after three months of oral supplementation by bioimpedance analysis	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	The interval between the beginning and the end of the single treatment was three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The interval between the blood collection performed at the beginning and the end of the single treatment was three months

Collaborators and Investigators

• Sponsor: University of Bari
• Investigators: Principal Investigator: Michele BARONE, Associate Professor, University of Bari

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 3, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 22, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia; Food for Special Medical Purposes; Rheumatologic diseases
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Connective Tissue Diseases; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Sarcopenia; Rheumatic Diseases; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Food
• Other Study ID Numbers: Protocol # 0084855/06/11/2020; Study # 6557 (Other Identifier: Policlinic University Hospital local ethics committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: I will share data upon formal request by other researchers.

Study Data/Documents

1. Study Protocol
   Information identifier: MBarone
   Information comments: Dataset can be obtained on request by sending an email to the following address: michele.barone@uniba.it

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No