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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Bioarginina C

Study type: Interventional

Funder types: Other

Identifiers

NCT06865261

6417

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bioarginina C

Control

Placebo Comparator group

Description:

Control group will receive placebo twice a day for 8 weeks

Treatment:

Dietary Supplement: Placebo