Early Nutritional Intervention in Patients Undergoing Liver Transplantation (NutLT)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Liver Transplant

Treatments: Dietary Supplement: protein and energy-rich supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07168369

20-238 21-371;

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Dietary Supplement: protein and energy-rich supplement

Control group

No Intervention group

Description:

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