The Effect of Early Nutritional Intervention on Muscle Mass in Patients Who Have Undergone Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Study feasibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cirrhosis listed for LT
- •French or English speaking
排除标准
- •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
研究组 & 干预措施
Intervention group
The intervention group received a protein and energy-rich supplement (1 bottle of 235mL per day for 12 weeks) in addition to standard care.
干预措施: protein and energy-rich supplement (Dietary Supplement)
Control group
The control group received standard care, which consists of a meeting with a registered dietitian providing routine dietary advice after surgery.
结局指标
主要结局
Study feasibility
时间窗: From enrollment to the end of treatment at 12 weeks
Feasibility of the study was assessed using a set of predefined indicators: the eligibility rate (% of patients on the waiting list who met eligibility criteria), the recruitment rate (% of eligible patients who agreed to participate), the target recruitment rate (% of participants enrolled relative to the predefined sample size), adherence to the protocol (% of participants who completed all planned data collection time points), and adherence to the intervention (% of participants who followed the nutritional intervention as intended). The attrition rate was also measured as the percentage of participants lost to follow-up or withdrawn after LT. The incidence of serious and non-serious adverse events during the study period was documented to evaluate the safety of the intervention.
Study feasibility
时间窗: From enrollment to the end of treatment at 12 weeks
Feasibility of the study was assessed using a set of predefined indicators: the eligibility rate (% of patients on the waiting list who met eligibility criteria), the recruitment rate (% of eligible patients who agreed to participate), the target recruitment rate (% of participants enrolled relative to the predefined sample size), adherence to the protocol (% of participants who completed all planned data collection time points), and adherence to the intervention (% of participants who followed the nutritional intervention as intended). The attrition rate was also measured as the percentage of participants lost to follow-up or withdrawn after LT. The incidence of serious and non-serious adverse events during the study period was documented to evaluate the safety of the intervention.
次要结局
- Nutritional risk(From enrollment to the end of treatment at 12 weeks)
- Muscle strength(From enrollment to the end of treatment at 12 weeks)
- Muscle mass(At admission for LT and at the end of treatment at 12 weeks)
- Health-related quality of life(From enrollment to the end of treatment at 12 weeks)
- Nutritional risk(From enrollment to the end of treatment at 12 weeks)
- Muscle strength(From enrollment to the end of treatment at 12 weeks)
- Muscle mass(At admission for LT and at the end of treatment at 12 weeks)
- Health-related quality of life(From enrollment to the end of treatment at 12 weeks)