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NCT Number: NCT07135388

Treatment of Rheumatologic Patients With Sarcopenia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food for special medical purposes

Dietary Supplement

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    Blood was collected at time zero and after three months of oral supplementation to evaluate some myokines (irisin, DBNF, decorin, myostatin) and IL-15.

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: REU-SA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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