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

June 6, 2025 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Abbott Nutrition

Investigators

  • Principal Investigator: Errol Bush, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

January 8, 2024

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00228299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing will be

IPD Sharing Time Frame

Data will be available upon completion of the study analysis

IPD Sharing Access Criteria

Upon request to principal investigator

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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