Lung Transplant; Complications
Conditions
Keywords
pre-hab, nutrition
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.
Interventions
DIETARY_SUPPLEMENTEnsure Enlive
Ensure Enlive shake twice a day
Sponsors
Abbott Nutrition
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Ensure Enlive, Nutritional shake, twice a day
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed