NCT06570174

Oral Protein Supplements for Nutritional and Quality of Life Improvement After Pancreatic Resection in Elderly Patients

Oral Protein Supplements Might Improve Nutritional Status and Quality of Life in Elderly Patients After Standard Pancreatic Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effects of oral protein supplements on the nutritional status and quality of life in elderly patients following standard pancreatic resection. The research aims to determine whether these supplements can improve protein intake and contribute to better skeletal muscle mass, which is critical for recovery and overall health. The study hypothesizes that higher compliance with protein supplementation will be positively correlated with increased protein intake and improved muscle mass index, potentially leading to enhanced postoperative outcomes in this patient population.

Detailed description

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.

Conditions

• Pancreatic Cancer
• Cholangiocarcinoma
• Intraductal Papillary Mucinous Neoplasm
• Neuroendocrine Tumor
• Solid Pseudopapillary Tumor

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral protein supplements	Participants in this group received an oral protein supplement providing 18g of protein per day. The supplement was administered postoperatively and continued throughout the study period. The goal was to assess the impact of protein supplementation on protein intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed. These outcomes were measured at three specific time points: before surgery, at discharge, and during the outpatient visit.
GENETIC	placebo	Participants in this group received a placebo supplement containing carbohydrates instead of protein, which was identical in appearance and taste to the protein supplement to maintain the study's double-blind design. The placebo was administered postoperatively and continued throughout the study period. The aim was to serve as a control to evaluate the effects of the protein supplement on outcomes including nutrient intake, nutritional status, quality of life, muscle mass, muscle strength, and 10-meter gait speed, measured at three key time points: before surgery, at discharge, and during the outpatient visit.

Timeline

• Start date: 2021-01-07
• Primary completion: 2022-07-18
• Completion: 2022-07-18
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: South Korea