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

Not Applicable

• Conditions: Lung Transplant; Complications
• Interventions: Dietary Supplement: Ensure Enlive

• Registration Number: NCT04522388
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-21
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Ensure Enlive	Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant

Primary Outcome Measures

Name	Time	Method
Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps	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

Name	Time	Method
Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level	Pre-transplant	To examine the effect of nutritional supplementation on Nutritional Risk index, measured by serum albumin level.

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States