Feasibility of Early Oral Nutritional Supplementation After Liver Transplantation: A Randomized Pilot Study

Catabolic and inflammatory changes after liver transplantation (LT) increase energy and protein requirements. This study assessed the feasibility of a 12-week high-energy/high-protein oral nutrition supplementation (ONS) initiated after resumption of solid oral intake post-LT. Secondary objectives were 1) to describe changes in nutritional risk, muscle strength, and quality of life during the pre-transplant period, and 2) to explore the potential impact of ONS after LT on these outcomes and muscle mass.

In this randomized feasibility study, patients awaiting LT were assessed for nutritional risk (Liver Disease Under nutrition Screening Tool), muscle strength (Chair Stand Test, CST), and quality of life (SF-36) before LT, every three months until surgery, at discharge, and again at 12 weeks post-LT. Muscle mass was assessed by CT scan at LT admission and 12 weeks later. After LT, participants were randomized to a control group or an intervention group receiving ONS for 12 weeks. Feasibility outcomes included eligibility, recruitment and target sample size, adherence to the protocol and intervention, attrition, and safety.

Of the seven predefined feasibility criteria, four were met, two were partially met (eligibility and recruitment rates), and one was not met (target sample size rate). Fifty-five patients were followed before LT, 17 underwent LT, and 14 were analyzed. Six patients developed new-onset diabetes after LT, limiting randomization to three patients in the intervention group and five in the control group. Before LT, 85.5% (47/55) of included patients were at risk of malnutrition, which remained stable during waiting time (p = 0.418), while muscle strength declined (p = 0.039). At 12 weeks post-LT, the intervention group had 0% malnutrition risk and a median CST time of 11.5 s, compared with 60% and 15.1 s, respectively, in the control group. The prevalence of sarcopenia did not change before and after the intervention.

Early post-LT ONS was feasible regarding adherence, retention, and safety; however, recruitment and achieving the targeted transplanted sample size were major barriers. The study highlights the high prevalence of malnutrition and sarcopenia before and after LT.

Early post-transplant nutritional supplementation showed feasibility for 4 of the 7 evaluated criteria. Most patients (85.5%) awaiting liver transplantation are at risk of malnutrition, with low and declining muscle strength during the waiting period. Challenges in participant recruitment suggest that refined recruitment approaches are needed for larger-scale studies.