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

Effects of L-arginine and Liposomal Vitamin C Supplementation on Physical Performance and Endothelial Function in Elderly With Sarcopenia

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Bioarginina C; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MATTEO TOSATO; Phone Number: +390630154859; Email: matteo.tosato@policlinicogemelli.it
• Study Contact Backup: Name: Giordana Gava; Phone Number: +390630155701; Email: giordana.gava@gmail.com

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario A. Gemelli IRCCS
    • Contact: MATTEO TOSATO; Phone Number: +390630154859; Email: matteo.tosato@policlinicogemelli.it
    • Contact: Matteo Tosato; Phone Number: +390630155701; Email: matteo.tosato@policlinicogemelli.it
    • Principal Investigator: Matteo Tosato
    • Sub-Investigator: Giordana Gava

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; the intervention group will receive twice-daily an oral supplementation with a combination of L-arginine 1.66 g plus liposomal Vitamin C 500 mg for 8 weeks	Dietary supplement: Bioarginina C; Bioarginine®C oral vials is a dietary supplement based on L-arginine and liposomal Vitamin C that is useful for making an integrative share of L-arginine and Vitamin C. Liposomal Vitamin C is a particular type of Vitamin C produced through an innovative technology that optimizes and amplifies its absorption.
Placebo Comparator: Control; Control group will receive placebo twice a day for 8 weeks	Dietary supplement: Placebo; Vials containing placebo were made to be indistinguishable in appearance from active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT	Change from baseline to day 56 in the distance walked on the 6 min walk test	2 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Matteo Tosato, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: aging; physical function; nitric oxide; muscle wasting; handgrip
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 6417

Drug and device information, study documents

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