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

NCT04522388 | Terminated DMC

• 1 other identifier: IRB00228299
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications

Keywords

pre-hab; nutrition

Outcome Measures

Primary Outcomes (1)

• Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps

  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 Outcomes (1)

• Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level

  Pre-transplant

Study Arms (1)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Ensure Enlive

Interventions

Ensure Enlive DIETARY_SUPPLEMENT

Ensure Enlive shake twice a day

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject with history of Galactosemia
• Subject with history of milk protein allergy
• Subject with history of soy protein allergy

Sponsors & Collaborators

• Johns Hopkins University: lead
• Abbott Nutrition: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 30447192 BACKGROUND

• 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.

  PMID: 23664761 BACKGROUND

Related Links

• Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung Transplantation
• Impact of nutritional state on lung transplant outcomes

Study Officials

• Errol Bush, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Ensure Enlive, Nutritional shake, twice a day

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: September 1, 2023
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available upon completion of the study analysis
• Access Criteria: Upon request to principal investigator

Locations

US (1)