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NCT04522388 Clinical Trial

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

Lung Transplant; Complications Clinical Trial

Official title:
A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04522388
Other study ID # IRB00228299
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date March 30, 2026

Study information
Verified date September 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 25
Est. completion date March 30, 2026
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ensure Enlive
Ensure Enlive shake twice a day

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Johns Hopkins University Abbott Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level To examine the effect of nutritional supplementation on Nutritional Risk index, measured by serum albumin level. Pre-transplant
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