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

NCT ID: NCT04522388

Last Updated: 2025-06-11

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

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-01-08

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Ensure Enlive, Nutritional shake, twice a day
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant

Group Type EXPERIMENTAL

Ensure Enlive

Intervention Type DIETARY_SUPPLEMENT

Ensure Enlive shake twice a day

Interventions

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Ensure Enlive

Ensure Enlive shake twice a day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Errol Bush, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Hsu J, Krishnan A, Lin CT, Shah PD, Broderick SR, Higgins RSD, Merlo CA, Bush EL. Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation. Ann Thorac Surg. 2019 Apr;107(4):1082-1088. doi: 10.1016/j.athoracsur.2018.10.006. Epub 2018 Nov 14.

Reference Type BACKGROUND
PMID: 30447192 (View on PubMed)

Chamogeorgakis T, Mason DP, Murthy SC, Thuita L, Raymond DP, Pettersson GB, Blackstone EH. Impact of nutritional state on lung transplant outcomes. J Heart Lung Transplant. 2013 Jul;32(7):693-700. doi: 10.1016/j.healun.2013.04.005. Epub 2013 May 9.

Reference Type BACKGROUND
PMID: 23664761 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/30447192

Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation

https://www.ncbi.nlm.nih.gov/pubmed/23664761

Impact of nutritional state on lung transplant outcomes

Other Identifiers

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IRB00228299

Identifier Type: -

Identifier Source: org_study_id

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