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

Sarcopenia Clinical Trial

— RE-COVID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04756856
• Other study ID #: 20210006520
• Status: Terminated
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: May 3, 2022

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 3, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Muscle-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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical performance - chair-stand	Change in chair-stand test	12 weeks
Secondary	Physical performance - chair-stand	Change in chair-stand test at the end of study	24 weeks
Secondary	Total body muscle mass	Change in total body muscle mass during the study	24 weeks
Secondary	Appendicular muscle mass	Change in appendicular muscle mass during the study	24 weeks
Secondary	Functional status - muscle strength	Change in handgrip strength during the study	24 weeks
Secondary	Fatigue	Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study	24 weeks
Secondary	Energy intake	Change in energy intake during the study	24 weeks
Secondary	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
Secondary	Body weight	Change in body weight during the study	24 weeks
Secondary	Serum levels of 25-hydroxy-vitamin D	Change in 25-hydroxy-vitamin D during the study	24 weeks