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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control | Placebo Comparator | Control group will receive placebo twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6MWT | Change from baseline to day 56 in the distance walked on the 6 min walk test | 2 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matteo Tosato | Contact | +390630154859 | matteo.tosato@policlinicogemelli.it | |
| Giordana Gava | Contact | +390630155701 | giordana.gava@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Matteo Tosato | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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|
| Placebo | Dietary Supplement | Vials containing placebo were made to be indistinguishable in appearance from active treatment |
|
| 2 months |
| FMD | Change from baseline to day 56 in flow mediated dilation valuesbetween treatment and control group | 2 months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |