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Early Nutritional Intervention in Patients Undergoing Liver Transplantation

NCT07168369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2025-01-06
Completion
2025-01-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168369 on ClinicalTrials.gov