Liver TransplantNutLTNCT07168369
Early Nutritional Intervention in Patients Undergoing Liver Transplantation
A study testing protein and energy-rich supplement in people with Liver Transplant, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The main goal of this clinical study is to assess the feasibility of a 12-week oral nutritional supplementation post-liver transplantation (LT). Secondary objectives includes evaluating changes in nutritional risk, muscle strength and mass, and quality of life during the pre-transplant period, as well as the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- protein and energy-rich supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2021to 6 Jan 2025
- 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
- patients with cirrhosis listed for LT
- French or English speaking
Who cannot join
- patients awaiting multiple organ transplants
- patients with acute liver failure or hepatocellular carcinoma
- patients who stayed in the intensive care unit for more than 30 days after LT
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
Official title: The Effect of Early Nutritional Intervention on Muscle Mass in Patients Who Have Undergone Liver Transplantation
The main goal of this clinical study is to assess the feasibility of a 12-week oral nutritional supplementation post-liver transplantation (LT). Secondary objectives includes evaluating changes in nutritional risk, muscle strength and mass, and quality of life during the pre-transplant period, as well as the intervention's potential impact post-LT. Following LT, participants are randomized to either: a control group, or an intervention group (high protein and energy oral supplement (235mL) for 12 week). Participants awaiting LT will complete questionnaires including nutritional risk (Liver Disease Undernutrition Screening Tool), muscle strength (Chair Stand Test), and quality of life (SF-36) every three months until surgery, at discharge after LT, and at 12 weeks. Muscle mass is measured by a computed tomography (CT) scan at admission for LT and at 12 weeks. Feasibility is assessed via eligibility rate, recruitment rate, target recruitment rate, protocol and intervention adherence, attrition rate, and safety.
- Conditions
- Liver Transplant
- Being tested
- protein and energy-rich supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein and energy-rich supplementDietary supplement
The nutritional supplements were provided in the form of ready-to-drink liquid solutions rich in protein and energy. Patients without diabetes received one 235 ml bottle per day of Ensure® Protéine Max (Abbott Nutrition, Montreal, Canada), which contained 350 kcal, 20 g of protein, 11 g of fat, 44 g of carbohydrates, 1.5 g of calcium-HMB and other essential micronutrients. Patients diagnosed with diabetes prior to LT received one 237 ml bottle per day of Boost® Diabetic (Nestlé, Montreal, Canada), which provided 190 kcal, 16 g of protein, 7 g of fat, 17 g of carbohydrates, and other essential micronutrients. Patients were instructed to consume the supplement in four equal doses of ~60 ml each, taken daily with breakfast, lunch, dinner, and as a bedtime snack, totaling one full bottle per day. The supplementation lasted for 12 weeks, beginning once solid oral feeding was initiated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group received a protein and energy-rich supplement (1 bottle of 235mL per day for 12 weeks) in addition to standard care. Receives: Dietary Supplement: protein and energy-rich supplement |
| Control group | No intervention | The control group received standard care, which consists of a meeting with a registered dietitian providing routine dietary advice after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility
Feasibility of the study was assessed using a set of predefined indicators: the eligibility rate (% of patients on the waiting list who met eligibility criteria), the recruitment rate (% of eligible patients who agreed to participate), the target recruitment rate (% of participants enrolled relative to the predefined sample size), adherence to the protocol (% of participants who completed all planned data collection time points), and adherence to the intervention (% of participants who followed the nutritional intervention as intended). The attrition rate was also measured as the percentage of participants lost to follow-up or withdrawn after LT. The incidence of serious and non-serious adverse events during the study period was documented to evaluate the safety of the intervention.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (4)
Nutritional risk
The nutritional risk of participants was assessed using the Liver Disease Undernutrition Screening Tool (LDUST), which is specifically designed for patients with chronic liver disease. This tool includes six questions addressing nutritional intake, weight loss, subcutaneous fat loss, muscle mass loss, fluid accumulation, and reduced functional capacity. The LDUST has shown good correlation with dietitian assessments of malnutrition. Using the LDUST, patients were classified into one of two categories: absence or presence of malnutrition risk.
Measured: From enrollment to the end of treatment at 12 weeks
Muscle strength
Muscle strength was assessed using the Chair Stand Test (CST), which provides a functional evaluation of muscle strength and endurance. The CST allows for a robust measure of lower limb function. Starting from a seated position, participants were asked to stand up and sit down without using their arms (the participant's arms were crossed over their chest) for a total of five times without assistance. The test was performed three times, and the average completion time was recorded. Patients unable to perform the test were assigned a score of 32 seconds. A completion time exceeding 15 seconds indicates reduced muscle strength
Measured: From enrollment to the end of treatment at 12 weeks
Muscle mass
Muscle mass was assessed using SMI measured by CT scan, the gold standard method for quantitative evaluation of sarcopenia. The skeletal muscle area was measured in cm2 from CT by segmenting muscles at the level of the third lumbar vertebra (L3) and normalized to height in m2. The SMI at the L3 level has demonstrated a strong correlation with clinical outcomes and with total body muscle mass. A SMI of less than 38.5 cm²/m² for women and less than 52.4 cm²/m² for men were used as cut-off values to define reduced muscle mass in this study. As recommended by EWGSOP, the diagnosis of sarcopenia was based on low SMI combined with reduced muscle strength, assessed using the CST.
Measured: At admission for LT and at the end of treatment at 12 weeks
Health-related quality of life
Quality of life was assessed using the Short Form 36 (SF-36) questionnaire, a validated and widely used tool for evaluating participants' perceptions of their quality of life. The SF-36 consists of 36 questions and covers 8 health dimensions: physical activity, limitations due to physical condition, limitations due to mental health, life and social relations, pain, vitality, mental health, and perceived health. Responses are scored from 0 to 100, with each dimension comprising 2 to 10 questions. The domain scores are further grouped into overall physical and mental health scores. Additionally, the SF-36 includes a question related to the evolution of health perceived by the patient. Higher scores reflect better quality of life.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Feb 2021
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168369
- Sponsor's protocol ID
- 20-238; 21-371
- Acronym
- NutLT
- Status last verified
- Oct 2020
- First submitted
- 4 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Nutritional Intervention on Muscle Mass in Patients Who Have Undergone Liver Transplantation
- ClinicalTrials.gov ID
- NCT07168369
- Acronym / sponsor ID
- NutLT / 20-238; 21-371
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 11 Sep 2025 (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.
The main goal of this clinical study is to assess the feasibility of a 12-week oral nutritional supplementation post-liver transplantation (LT). Secondary objectives includes evaluating changes in nutritional risk, muscle strength and mass, and quality of life during the pre-transplant period, as well as the intervention's potential impact post-LT. Following LT, participants are randomized to either: a control group, or an intervention group (high protein and energy oral supplement (235mL) for 12 week). Participants awaiting LT will complete questionnaires including nutritional risk (Liver Disease Undernutrition Screening Tool), muscle strength (Chair Stand Test), and quality of life (SF-36) every three months until surgery, at discharge after LT, and at 12 weeks. Muscle mass is measured by a computed tomography (CT) scan at admission for LT and at 12 weeks. Feasibility is assessed via eligibility rate, recruitment rate, target recruitment rate, protocol and intervention adherence, attrition rate, and safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: protein and energy-rich supplementThe intervention group received a protein and energy-rich supplement (1 bottle of 235mL per day for 12 weeks) in addition to standard care. |
| Control group | No intervention | –The control group received standard care, which consists of a meeting with a registered dietitian providing routine dietary advice after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with cirrhosis listed for LT
- French or English speaking
Key exclusion criteria (3 listed)
- patients awaiting multiple organ transplants
- patients with acute liver failure or hepatocellular carcinoma
- patients who stayed in the intensive care unit for more than 30 days after LT
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 |
|---|---|---|
| protein and energy-rich supplementThe nutritional supplements were provided in the form of ready-to-drink liquid solutions rich in protein and energy. Patients without diabetes received one 235 ml bottle per day of Ensure® Protéine Max (Abbott Nutrition, Montreal, Canada), which contained 350 kcal, 20 g of protein, 11 g of fat, 44 g of carbohydrates, 1.5 g of calcium-HMB and other essential micronutrients. Patients diagnosed with diabetes prior to LT received one 237 ml bottle per day of Boost® Diabetic (Nestlé, Montreal, Canada), which provided 190 kcal, 16 g of protein, 7 g of fat, 17 g of carbohydrates, and other essential micronutrients. Patients were instructed to consume the supplement in four equal doses of ~60 ml each, taken daily with breakfast, lunch, dinner, and as a bedtime snack, totaling one full bottle per day. The supplementation lasted for 12 weeks, beginning once solid oral feeding was initiated. | Dietary supplement | Intervention group |
Primary outcome
Study feasibility
Time frame: From enrollment to the end of treatment at 12 weeks
Feasibility of the study was assessed using a set of predefined indicators: the eligibility rate (% of patients on the waiting list who met eligibility criteria), the recruitment rate (% of eligible patients who agreed to participate), the target recruitment rate (% of participants enrolled relative to the predefined sample size), adherence to the protocol (% of participants who completed all planned data collection time points), and adherence to the intervention (% of participants who followed the nutritional intervention as intended). The attrition rate was also measured as the percentage of participants lost to follow-up or withdrawn after LT. The incidence of serious and non-serious adverse events during the study period was documented to evaluate the safety of the intervention.
4 secondary outcomes
Nutritional risk
Time frame: From enrollment to the end of treatment at 12 weeks
Muscle strength
Time frame: From enrollment to the end of treatment at 12 weeks
Muscle mass
Time frame: At admission for LT and at the end of treatment at 12 weeks
Health-related quality of life
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein and energy-rich supplement in people with Liver Transplant, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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: finished, as of the sponsor's last update on 15 Sep 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study feasibility (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.