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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Bioarginina C

Intervention Type 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.

Control

Control group will receive placebo twice a day for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No