The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease
The Effect of Dietary Intervention on Muscle Strength in Patients With Liver Cirrhosis
Liver cirrhosis can lead to weakness, frailty, and poor quality of life, even in patients whose disease is still in a relatively stable phase. Many people with cirrhosis have low muscle strength and frailty, but these problems often go unrecognised and untreated. This study is testing whether a personalised diet plan, focused on adequate calories and protein from regular foods, together with nutrition counselling, can improve muscle strength, frailty, and quality of life in outpatients with stable cirrhosis.
In this study, about 70 adults with compensated or early decompensated liver cirrhosis are randomly assigned to one of two groups. One group receives an individualised, food-based meal plan designed to provide about 30-35 kilocalories per kilogram per day and 1.2-1.5 grams of protein per kilogram per day, along with regular counselling by a diet professional. The other group continues with their usual medical care and does not receive a specific diet plan. No nutritional supplements are used.
Participants are followed for 16 weeks. During this time, the research team measures handgrip strength as the main outcome, and also assesses frailty and health-related quality of life using standard questionnaires and tests. The goal is to find out whether an individualised dietary intervention, using only food-based strategies and counselling, can safely help maintain or improve muscle strength, reduce frailty, and enhance quality of life in people living with liver cirrhosis.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Lazio
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Rome、Lazio、意大利、00185
- Policlinico Umberto I
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria: ● Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, radiological, and/or histological evidence.
- Outpatients who were clinically stable at the time of enrolment.
- Child-Turcotte-Pugh (CTP) score ≤ 10.
Exclusion Criteria:
- Already receiving a structured nutrition intervention program or high-protein supplementation.
- Presence of other severe co-morbidities that could confound outcomes.
- History of chronic or recurrent hepatic encephalopathy.
- Active alcohol consumption at the time of screening.
- Expected poor compliance with study procedures.
- Refusal to provide consent for participation.
- Pregnant or lactating women.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Intervention Group
Patients received personalized dietary charts tailored to provide an energy intake of 30-35 kcal/kg/day.
In overweight or obese individuals, a moderately hypocaloric diet (-500 to -800 kcal/day) was prescribed, consistent with established international guidelines.
Protein intake was targeted at 1.2-1.5 g/kg ideal body weight (IBW)/day, with a macronutrient distribution of approximately 55-60% carbohydrates, 20% protein, and 20-25% fat.
In addition, patients received structured nutritional counselling at enrolment, which reinforced dietary goals and strategies for adherence.
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Energy intake : 30-35 kcal/kg/day (if overweight or obese individuals -500 to -800 kcal/day). Protein intake : 1.2-1.5 g/kg/day |
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无干预：Control Group
Patients in the control group did not receive any individualized dietary prescriptions or structured nutritional counselling.
They continued their routine clinical management as per standard care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in handgrip strength (kg) from baseline to Week 16 measured using a Hand Dynamometer
大体时间：Baseline and 16 weeks
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Muscle strength is assessed using a calibrated Jamar® Hydraulic Hand Dynamometer (Performance Health International Ltd., Nottinghamshire, UK), following standardized protocols. Participants are seated upright with the shoulder adducted, elbow flexed at 90°, and the forearm and wrist in a neutral position. The dynamometer is held in the dominant hand unless contraindicated, in which case the non-dominant hand is used. Each participant is instructed to squeeze the device with maximum effort for a few seconds, with standardized verbal encouragement provided to ensure optimal performance. The average of three measurements are recorded and expressed in kilograms (kg). |
Baseline and 16 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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