Clinical trial NCT06865261: Effects of L-ARGinine and Liposomal Vitamin C Supplementation On Physical Performance
Official title: Effects of L-arginine and Liposomal Vitamin C Supplementation on Physical Performance and Endothelial Function in Elderly With Sarcopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: aging
muscle wasting
physical function
handgrip
nitric oxide
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6MWT
timeFrame: 2 months
Secondary outcomes:
measure: HG
timeFrame: 2 months
measure: CST
timeFrame: 2 months
measure: FMD
timeFrame: 2 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Matteo Tosato
role: PRINCIPAL_INVESTIGATOR
References: