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Significant change in the profile of recruitable patients
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle-target oral nutritional supplementation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical performance - chair-stand | Change in chair-stand test | 12 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Cereda, MD | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Riccardo Caccialanza, MD | Fondazione IRCCS Policlinico San Matteo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32961041 | Background | 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. | |
| 31278117 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| 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 |
| Background |
| Barichella 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |