Effects of L-ARGinine and Liposomal Vitamin C Supplementation On Physical Performance

Not Applicable

Recruiting

• Conditions: Sarcopenia

• Registration Number: NCT06865261
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

In older age, reduced mobility is associated with an increased risk of reduced quality of life, disability, institutionalisation, and death, as well as increased healthcare expenditures. Sarcopenia is a condition characterised by a reduction in muscle mass and strength and/or function. It is associated with several adverse outcomes, such as falls, increased risk of infection, disability, institutionalisation, and death. Currently, no pharmacological treatments are available to combat sarcopenia. The management of sarcopenia relies on the adoption of an active lifestyle, comprising resistance exercise, which may be supported by an adequate intake of protein with the diet. Recently, treatment with L-arginine and liposomal vitamin C has been shown to significantly reduce fatigue, and improve physical performance and endothelial reactivity in adult patients with Long COVID. Long COVID may be considered a model of accelerated ageing, as it recapitulates several age-associated biological processes, including chronic inflammation, oxidative stress, endothelial dysfunction and malnutrition.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-20
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• probable sarcopenia defined according to EWGSOP2 criteria

Exclusion Criteria

• Inability or unwillingness to provide informed consent;
• NH residents;
• schizophrenia or other psychotic disorders, bipolar syndrome;
• consumption of more than 14 alcoholic beverages per week;
• reduced cognitive performance (Mini-Mental State Examination score <26);
• severe arthrosis;
• malignancies requiring treatment in the previous 3 years;
• lung disease requiring chronic corticosteroid therapy or oxygen therapy;
• severe cardiovascular disease;
• Parkinson's disease or other developmental neurological disorders;
• renal failure undergoing dialysis treatment;
• chest pain, severe dyspnea or conditions that may pose safety concerns when performing the 6-minute test or chair test;
• other medical, psychiatric or behavioral factors that, in the judgment of the researcher, may interfere with participation in the study;
• other illnesses related to an estimated life expectancy of less than 12 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6MWT	2 months	Change from baseline to day 56 in the distance walked on the 6 min walk test

Secondary Outcome Measures

Name	Time	Method
HG	2 months	Change from baseline to day 56 in handgrip strength
CST	2 months	Change from baseline to day 56 in time to complete 5-repetition chair stand test
FMD	2 months	Change from baseline to day 56 in flow mediated dilation valuesbetween treatment and control group

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy