Early Nutritional Intervention in Patients Undergoing Liver Transplantation

NCT ID: NCT07168369

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2025-01-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

The intervention group received a protein and energy-rich supplement (1 bottle of 235mL per day for 12 weeks) in addition to standard care.

Group Type: EXPERIMENTAL

protein and energy-rich supplement

Intervention Type: 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.

Control group

The control group received standard care, which consists of a meeting with a registered dietitian providing routine dietary advice after surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

protein and energy-rich 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 Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

20-238; 21-371

Identifier Type: -

Identifier Source: org_study_id