This study was a randomized, double-blind, placebo-controlled clinical trial conducted to assess the effects of oral protein supplements on nutritional status and quality of life in elderly patients following pancreaticobiliary surgery. The study included elderly patients aged 65 years or older who underwent surgery for pancreaticobiliary cancer. The trial was conducted between January 7, 2021, and July 18, 2022.
A total of 60 patients were initially enrolled, but after 19 dropouts, the final analysis was based on 41 patients (18 in the placebo group and 23 in the experimental group). The experimental group received protein supplements providing 18g of protein per day, while the control group received a placebo containing carbohydrates instead of protein.
Key outcomes such as nutrient intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed were measured at three time points: before surgery, at discharge, and during an outpatient visit. The data were analyzed using a Linear Mixed-Effects Model to evaluate the effects of the intervention.