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Muscle-targeted Nutritional Therapy for the Recovery From COVID-19 (RE-COVID)

Primary Purpose

Sarcopenia

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Muscle-target oral nutritional supplementation
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle-target oral nutritional supplementation

Arm Description

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

Outcomes

Primary Outcome Measures

Physical performance - chair-stand
Change in chair-stand test

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2021
Last Updated
September 21, 2023
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT04756856
Brief Title
Muscle-targeted Nutritional Therapy for the Recovery From COVID-19
Acronym
RE-COVID
Official Title
Impact of a Muscle-targeted Nutritional Therapy in the Recovery of Post-discharge COVID19 Patients Suffering From Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Significant change in the profile of recruitable patients
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle-target oral nutritional supplementation
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Muscle-target oral nutritional supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical performance - chair-stand
Description
Change in chair-stand test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical performance - chair-stand
Description
Change in chair-stand test at the end of study
Time Frame
24 weeks
Title
Total body muscle mass
Description
Change in total body muscle mass during the study
Time Frame
24 weeks
Title
Appendicular muscle mass
Description
Change in appendicular muscle mass during the study
Time Frame
24 weeks
Title
Functional status - muscle strength
Description
Change in handgrip strength during the study
Time Frame
24 weeks
Title
Fatigue
Description
Change in fatigue as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) during the study
Time Frame
24 weeks
Title
Energy intake
Description
Change in energy intake during the study
Time Frame
24 weeks
Title
Self-perceived quality of life
Description
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
Time Frame
24 weeks
Title
Body weight
Description
Change in body weight during the study
Time Frame
24 weeks
Title
Serum levels of 25-hydroxy-vitamin D
Description
Change in 25-hydroxy-vitamin D during the study
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuele Cereda, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32961041
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.
Results Reference
background
PubMed Identifier
31278117
Citation
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.
Results Reference
background

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

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