SarcopeniaARGONCT06865261
Effects of L-ARGinine and Liposomal Vitamin C Supplementation On Physical Performance
A study testing Bioarginina C in people with Sarcopenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Bioarginina C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- probable sarcopenia defined according to EWGSOP2 criteria
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
MATTEO TOSATO, +390630154859, matteo.tosato@policlinicogemelli.it
Matteo Tosato, +390630155701, matteo.tosato@policlinicogemelli.it
About this study
Official title: Effects of L-arginine and Liposomal Vitamin C Supplementation on Physical Performance and Endothelial Function in Elderly With Sarcopenia
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
- Being tested
- Bioarginina C, Placebo
- Keywords
- aging, muscle wasting, physical function, handgrip, nitric oxide
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioarginina CDietary 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.
PlaceboDietary supplement
Vials containing placebo were made to be indistinguishable in appearance from active treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Bioarginina C |
| Control | Placebo comparator | Control group will receive placebo twice a day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
Change from baseline to day 56 in the distance walked on the 6 min walk test
Measured: 2 months
Secondary outcomes (3)
HG
Change from baseline to day 56 in handgrip strength
Measured: 2 months
CST
Change from baseline to day 56 in time to complete 5-repetition chair stand test
Measured: 2 months
FMD
Change from baseline to day 56 in flow mediated dilation valuesbetween treatment and control group
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 May 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Tosato, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865261
- Sponsor's protocol ID
- 6417
- Acronym
- ARGO
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-arginine and Liposomal Vitamin C Supplementation on Physical Performance and Endothelial Function in Elderly With Sarcopenia
- ClinicalTrials.gov ID
- NCT06865261
- Acronym / sponsor ID
- ARGO / 6417
- Conditions
- Sarcopenia
- Keywords
- aging, muscle wasting, physical function, handgrip, nitric oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Bioarginina Cthe 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 | Dietary Supplement: PlaceboControl group will receive placebo twice a day for 8 weeks |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- probable sarcopenia defined according to EWGSOP2 criteria
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioarginina CBioarginine®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 supplement | Experimental Group |
| PlaceboVials containing placebo were made to be indistinguishable in appearance from active treatment | Dietary supplement | Control |
Primary outcome
6MWT
Time frame: 2 months
Change from baseline to day 56 in the distance walked on the 6 min walk test
3 secondary outcomes
HG
Time frame: 2 months
CST
Time frame: 2 months
FMD
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Tosato principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioarginina C in people with Sarcopenia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Tosato (+390630154859, matteo.tosato@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.