NCT04756856
Terminated
Not Applicable
Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia
Fondazione IRCCS Policlinico San Matteo di Pavia1 site in 1 country5 target enrollmentApril 21, 2021
ConditionsSarcopenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Physical performance - chair-stand
- Status
- Terminated
- Last Updated
- last year
Overview
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, on the recovery of post-COVID-19 patients
Investigators
Emanuele Cereda
Principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Eligibility Criteria
Inclusion Criteria
- •Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
- •Recent discharge from hospital for COVID-19
- •Informed consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Physical performance - chair-stand
Time Frame: 12 weeks
Change in chair-stand test
Secondary Outcomes
- Total body muscle mass(24 weeks)
- Appendicular muscle mass(24 weeks)
- Fatigue(24 weeks)
- Body weight(24 weeks)
- Functional status - muscle strength(24 weeks)
- Self-perceived quality of life(24 weeks)
- Serum levels of 25-hydroxy-vitamin D(24 weeks)
- Physical performance - chair-stand(24 weeks)
- Energy intake(24 weeks)
Study Sites (1)
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