Treatment of Rheumatologic Patients With Sarcopenia

NCT07135388 | Completed

• 2 other identifiers: Protocol # 0084855/06/11/2020Study # 6557
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Diseases

Keywords

Sarcopenia; Rheumatologic diseases; Food for Special Medical Purposes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assessment of myokines and cytokines blood levels

  The interval between the blood collection performed at the beginning and the end of the single treatment was three months

Study Arms (1)

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)

Dietary Supplement: Food for special medical purposes

Interventions

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)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Polyclinic University Hospital

Bari, BA, 70124, Italy

Location

Related Publications (1)

• 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.

  PMID: 30513782 BACKGROUND

MeSH Terms

Conditions

Rheumatic Diseases; Sarcopenia

Interventions

Food

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michele BARONE, Associate Professor

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 22, 2025
• Study Start: January 31, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

IT (1)