SarcopeniaRE-COVIDNCT04756856
Muscle-targeted Nutritional Therapy for the Recovery From COVID-19
A study testing Muscle-target oral nutritional supplementation in people with Sarcopenia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Muscle-target oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2021to 3 May 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
- Recent discharge from hospital for COVID-19
- Informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Who cannot join
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- Indications related to the study product:
Show all 9Show fewer
- More than 10 µg (400 IU) of daily Vitamin D intake from medical sources. More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- Known allergy to milk, milk products or other components of the proposed interventions
- Indication to or ongoing artificial nutrition support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia
To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients
- Conditions
- Sarcopenia
- Being tested
- Muscle-target oral nutritional supplementation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle-target oral nutritional supplementationOther
Patients will receive daily for 12 weeks two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D. Patients will be also followed for 12 weeks after the suspension of supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Muscle-target oral nutritional supplementation | Experimental | Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D Receives: Other: Muscle-target oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance - chair-stand
Change in chair-stand test
Measured: 12 weeks
Secondary outcomes (9)
Physical performance - chair-stand
Change in chair-stand test at the end of study
Measured: 24 weeks
Total body muscle mass
Change in total body muscle mass during the study
Measured: 24 weeks
Appendicular muscle mass
Change in appendicular muscle mass during the study
Measured: 24 weeks
Functional status - muscle strength
Change in handgrip strength during the study
Measured: 24 weeks
Fatigue
Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study
Measured: 24 weeks
Energy intake
Change in energy intake during the study
Measured: 24 weeks
Self-perceived quality of life
Change in quality of life during the study as assessed by the five-level EuroQol five-dimensional (EQ-5D-5L) descriptive system during the study
Measured: 24 weeks
Body weight
Change in body weight during the study
Measured: 24 weeks
Serum levels of 25-hydroxy-vitamin D
Change in 25-hydroxy-vitamin D during the study
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start21 Apr 2021
- Primary completion1 May 2022
- Study completion3 May 2022
Why it stopped: Significant change in the profile of recruitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Cereda, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Emanuele Cereda, MD, Principal investigator, Fondazione IRCCS Policlinico San MatteoRiccardo Caccialanza, MD, Study director, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756856
- Sponsor's protocol ID
- 20210006520
- Acronym
- RE-COVID
- Status last verified
- Apr 2025
- First submitted
- 15 Feb 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.
PubMed 32961041Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5.
PubMed 31278117
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia
- ClinicalTrials.gov ID
- NCT04756856
- Acronym / sponsor ID
- RE-COVID / 20210006520
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant change in the profile of recruitable patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 16 Feb 2021 (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.
To assess the impact of a muscle-targeted nutritional therapy consisting of nutritional counseling and high-quality whey protein-based oral nutritional supplements enriched with leucine and vitamin D, on the recovery of post-COVID-19 patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle-target oral nutritional supplementation | Experimental | Other: Muscle-target oral nutritional supplementationTwo servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
- Recent discharge from hospital for COVID-19
- Informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Key exclusion criteria (9 listed)
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
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 |
|---|---|---|
| Muscle-target oral nutritional supplementationPatients will receive daily for 12 weeks two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D. Patients will be also followed for 12 weeks after the suspension of supplementation. | Other | Muscle-target oral nutritional supplementation |
Primary outcome
Physical performance - chair-stand
Time frame: 12 weeks
Change in chair-stand test
9 secondary outcomes
Physical performance - chair-stand
Time frame: 24 weeks
Total body muscle mass
Time frame: 24 weeks
Appendicular muscle mass
Time frame: 24 weeks
Functional status - muscle strength
Time frame: 24 weeks
Fatigue
Time frame: 24 weeks
Energy intake
Time frame: 24 weeks
Self-perceived quality of life
Time frame: 24 weeks
Body weight
Time frame: 24 weeks
Serum levels of 25-hydroxy-vitamin D
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Significant change in the profile of recruitable patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 32961041Rondanelli M, Cereda E, Klersy C, Faliva MA, Peroni G, Nichetti M, Gasparri C, Iannello G, Spadaccini D, Infantino V, Caccialanza R, Perna S. Improving rehabilitation in sarcopenia: a randomized-controlled trial utilizing a muscle-targeted food for special medical purposes. J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1535-1547. doi: 10.1002/jcsm.12532. Epub 2020 Sep 22.
- Background: PubMed 31278117Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5.
- Individual participant dataSharing planned: No
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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.
Emanuele Cereda, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
Riccardo Caccialanza, MD study director
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle-target oral nutritional supplementation in people with Sarcopenia, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 May 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. 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?
The study was stopped early (reason given: Significant change in the profile of recruitable patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance - chair-stand (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756856, which also lists 2 linked publications.
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 1 May 2025.