Status:
TERMINATED
Muscle-targeted Nutritional Therapy for the Recovery From COVID-19
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Sarcopenia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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,...
Eligibility Criteria
Inclusion
- Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
- Recent discharge from hospital for COVID-19
- Informed consent
Exclusion
- 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:
- 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
- Inclusion in other nutrition intervention trials
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04756856
Start Date
April 21 2021
End Date
May 3 2022
Last Update
May 1 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100