Sarcopenia
Conditions
Keywords
aging, muscle wasting, physical function, handgrip, nitric oxide
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.
Interventions
DIETARY_SUPPLEMENTBioarginina 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.
DIETARY_SUPPLEMENTPlacebo
Vials containing placebo were made to be indistinguishable in appearance from active treatment
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6MWT | 2 months | Change from baseline to day 56 in the distance walked on the 6 min walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactMatteo Tosato
Backup ContactGiordana Gava
Outcome results
None listed