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

Not Applicable

Terminated

• Conditions: Sarcopenia
• Interventions: Other: Muscle-target oral nutritional supplementation

• Registration Number: NCT04756856
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Study Start: 2021-04-21
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle-target oral nutritional supplementation	Muscle-target oral nutritional supplementation	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

Primary Outcome Measures

Name	Time	Method
Physical performance - chair-stand	12 weeks	Change in chair-stand test

Secondary Outcome Measures

Name	Time	Method
Total body muscle mass	24 weeks	Change in total body muscle mass during the study
Energy intake	24 weeks	Change in energy intake during the study
Appendicular muscle mass	24 weeks	Change in appendicular muscle mass 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
Body weight	24 weeks	Change in body weight during the study
Functional status - muscle strength	24 weeks	Change in handgrip strength during the 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
Serum levels of 25-hydroxy-vitamin D	24 weeks	Change in 25-hydroxy-vitamin D during the study
Physical performance - chair-stand	24 weeks	Change in chair-stand test at the end of study

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy