Lung Transplant; ComplicationsNCT04522388
Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
A study testing Ensure Enlive in people with Lung Transplant; Complications, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Ensure Enlive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years or older who are listed for single or double lung transplant
- Subject provides written informed consent to participate in this study
Who cannot join
- Subject with history of Galactosemia
- Subject with history of milk protein allergy
- Subject with history of soy protein allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
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
- Being tested
- Ensure Enlive
- Keywords
- pre-hab, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure EnliveDietary supplement
Ensure Enlive shake twice a day
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Nutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant Receives: Dietary Supplement: Ensure Enlive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-transplant
Secondary outcomes (1)
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.
Measured: Pre-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Sep 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Why it stopped: due to lack of enrollment and sponsored funding for this project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Ensure Enlive, Nutritional shake, twice a day
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Nutrition
- Responsible party
- Sponsor
- Investigators
- Errol Bush, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522388
- Sponsor's protocol ID
- IRB00228299
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2020
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be
Publications
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.
PubMed 30447192Chamogeorgakis 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.
PubMed 23664761
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant
- ClinicalTrials.gov ID
- NCT04522388
- Acronym / sponsor ID
- IRB00228299
- Conditions
- Lung Transplant; Complications
- Keywords
- pre-hab, nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of enrollment and sponsored funding for this project
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Abbott Nutrition
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Ensure Enlive, Nutritional shake, twice a day
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Ensure EnliveNutritional shakes, Ensure Enlive, twice per day orally in patients awaiting lung transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects 18 years or older who are listed for single or double lung transplant
- Subject provides written informed consent to participate in this study
Key exclusion criteria (3 listed)
- Subject with history of Galactosemia
- Subject with history of milk protein allergy
- Subject with history of soy protein allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure EnliveEnsure Enlive shake twice a day | Dietary supplement | Treatment |
Primary outcome
Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps
Time frame: 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.
1 secondary outcome
Effect of nutritional supplementation on Nutritional Risk index as assessed by serum albumin level
Time frame: Pre-transplant
Results and safety
The study was stopped early (reason given: due to lack of enrollment and sponsored funding for this project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 30447192Hsu 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.
- Background: PubMed 23664761Chamogeorgakis 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.
- Sarcopenia of the Psoas Muscles Is Associated With Poor Outcomes Following Lung TransplantationLink provided by the sponsor.
- Impact of nutritional state on lung transplant outcomesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data sharing will be
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Errol Bush, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Enlive in people with Lung Transplant; Complications, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to lack of enrollment and sponsored funding for this project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nutritional supplementation on skeletal muscle mass as assessed by ultrasound of the quadriceps (time frame: Pre-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522388, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.