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

NCT04756856 | Terminated DMC

• 1 other identifier: 20210006520
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Physical performance - chair-stand

  Change in chair-stand test

  12 weeks

Secondary Outcomes (9)

• Physical performance - chair-stand

  24 weeks

• Total body muscle mass

  24 weeks

• Appendicular muscle mass

  24 weeks

• Functional status - muscle strength

  24 weeks

• Fatigue

  24 weeks

Study Arms (1)

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

Other: Muscle-target oral nutritional supplementation

Interventions

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.

Muscle-target oral nutritional supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcopenia (revised European Working Group on Sarcopenia in Older People criteria)
• Recent discharge from hospital for COVID-19
• Informed consent

You may not qualify if:

• 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
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• Refusal

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (2)

• 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.

  PMID: 32961041 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.

  PMID: 31278117 BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Emanuele Cereda, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

• Riccardo Caccialanza, MD

  Fondazione IRCCS Policlinico San Matteo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 16, 2021
• Study Start: April 21, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 3, 2022
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)