Sarcopenia
Conditions
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
Interventions
OTHERMuscle-target oral nutritional supplementation
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.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * Refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance - chair-stand | 12 weeks | Change in chair-stand test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total body muscle mass | 24 weeks | Change in total body muscle mass during the study |
| Appendicular muscle mass | 24 weeks | Change in appendicular muscle mass during the study |
| Functional status - muscle strength | 24 weeks | Change in handgrip strength during the study |
| Fatigue | 24 weeks | Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study |
| Physical performance - chair-stand | 24 weeks | Change in chair-stand test at the end of study |
| Self-perceived quality of life | 24 weeks | 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 |
| Body weight | 24 weeks | Change in body weight during the study |
| Serum levels of 25-hydroxy-vitamin D | 24 weeks | Change in 25-hydroxy-vitamin D during the study |
| Energy intake | 24 weeks | Change in energy intake during the study |
Countries
Italy
Outcome results
None listed