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

NCT06865261 | Recruiting

• 1 other identifier: 6417
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

aging; muscle wasting; physical function; handgrip; nitric oxide

Outcome Measures

Primary Outcomes (1)

• 6MWT

  Change from baseline to day 56 in the distance walked on the 6 min walk test

  2 months

Secondary Outcomes (3)

• HG

  2 months

• CST

  2 months

• FMD

  2 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Control group will receive placebo twice a day for 8 weeks

Dietary Supplement: Placebo

Interventions

Bioarginina C DIETARY_SUPPLEMENT

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.

Experimental Group

Placebo DIETARY_SUPPLEMENT

Vials containing placebo were made to be indistinguishable in appearance from active treatment

Control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• probable sarcopenia defined according to EWGSOP2 criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Matteo Tosato

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Tosato

CONTACT

+390630154859; matteo.tosato@policlinicogemelli.it

Giordana Gava

CONTACT

+390630155701; giordana.gava@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: March 7, 2025
• Study Start: May 20, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-05

Locations

IT (1)