Liver Cirrhosis
Conditions
Keywords
Nutrition, Muscle Strength, Diet, Liver cirrhosis
Brief summary
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.
Interventions
OTHERIndividualized diet
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
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in handgrip strength (kg) from baseline to Week 16 measured using a Hand Dynamometer | Baseline and 16 weeks | 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). |
Countries
Italy
Outcome results
None listed