Muscle-targeted Nutritional Therapy for the Recovery From COVID-19

Study Overview
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Brief Summary
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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

Official Title
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Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: Muscle-target oral nutritional supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle-target oral nutritional supplementation<br>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 | Other: Muscle-target oral nutritional supplementation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance - chair-stand | Change in chair-stand test | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance - chair-stand | Change in chair-stand test at the end of study | 24 weeks | 
| Total body muscle mass | Change in total body muscle mass during the study | 24 weeks | 
| Appendicular muscle mass | Change in appendicular muscle mass during the study | 24 weeks | 
| Functional status - muscle strength | Change in handgrip strength during the study | 24 weeks | 
| Fatigue | Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study | 24 weeks | 
| Energy intake | Change in energy intake during the study | 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 | 24 weeks | 
| Body weight | Change in body weight during the study | 24 weeks | 
| Serum levels of 25-hydroxy-vitamin D | Change in 25-hydroxy-vitamin D during the study | 24 weeks |