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

Johns Hopkins University

Status: Terminated

Conditions: Lung Transplant; Complications

Treatments: Dietary Supplement: Ensure Enlive

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04522388

IRB00228299

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ensure Enlive