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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-21

Study Completion Date

2022-05-03

Brief Summary

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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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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Muscle-target oral nutritional supplementation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No