Early Nutritional Intervention in Patients Undergoing Liver Transplantation

NCT07168369 | Completed

• 1 other identifier: 20-238; 21-371
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 The attrition rate was also measured as the percentage of participants lost to follow-up or withdrawn after LT.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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (4)

• Nutritional risk

  From enrollment to the end of treatment at 12 weeks

• Muscle strength

  From enrollment to the end of treatment at 12 weeks

• Muscle mass

  At admission for LT and at the end of treatment at 12 weeks

• Health-related quality of life

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

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.

Interventions

protein and energy-rich supplement DIETARY_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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cirrhosis listed for LT
• French or English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre de recherche du Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: February 15, 2021
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: September 15, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)