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Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522388
Recruitment Status : Not yet recruiting
First Posted : August 21, 2020
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
Abbott Nutrition
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
This non-randomized pilot study aims to investigate whether a protein rich nutritional shake (Ensure Enlive) given to patients pre-transplant will decrease skeletal muscle loss (measured by quadriceps ultrasound) and improve nutritional state (measured by Nutritional Risk Index). A nutritional supplement would be a cost-effective solution to treat malnutrition, a known risk factor implicated in poor outcomes for lung transplant recipients.

Condition or disease Intervention/treatment Phase
Lung Transplant; Complications Dietary Supplement: Ensure Enlive Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Ensure Enlive, Nutritional shake, twice a day
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant
 Dietary Supplement: Ensure Enlive
Ensure Enlive shake twice a day


Outcome Measures
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Primary Outcome Measures :
  1. Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps [ Time Frame: Pre-transplant ]
    To examine the effect of nutritional supplementation on skeletal muscle mass in patients with end stage lung disease who are awaiting lung transplant, measured by ultrasound of the quadriceps.


Secondary Outcome Measures :
  1. Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level [ Time Frame: Pre-transplant ]
    To examine the effect of nutritional supplementation on Nutritional Risk index, measured by serum albumin level.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects 18 years or older who are listed for single or double lung transplant
  • Subject provides written informed consent to participate in this study

Exclusion Criteria:

  • Subject with history of Galactosemia
  • Subject with history of milk protein allergy
  • Subject with history of soy protein allergy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522388


Contacts
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Contact: Errol Bush, MD 410-614-3891 errol.bush@jhu.edu
Contact: Judi Willhide, RN 410-955-3597 jwillhi3@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Abbott Nutrition
Investigators
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Principal Investigator: Errol Bush, MD Johns Hopkins University
More Information
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Additional Information:

Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04522388    
Other Study ID Numbers: IRB00228299
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing will be
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available upon completion of the study analysis
Access Criteria: Upon request to principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
pre-hab
nutrition