The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease
Key facts
- Who runs it
- University of Roma La Sapienza
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 70 people enrolled
- Started
- 7 Mar 2023
- Ended
- 20 Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Individualized diet
- Record updated
- 4 June 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Outpatients who were clinically stable at the time of enrolment
- Child-Turcotte-Pugh (CTP) score ≤ 10
Who cannot take part
- Already receiving a structured nutrition intervention program or high-protein supplementation
- History of chronic or recurrent hepatic encephalopathy
- Presence of other severe co-morbidities that could confound outcomes
- Active alcohol consumption at the time of screening
- Expected poor compliance with study procedures
- Refusal to provide consent for participation
- Pregnant or lactating women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention GroupExisting treatment, for comparison
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.
Treatment: Individualized diet
- Control GroupNo study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Dietary Intervention on Muscle Strength in Patients With Liver Cirrhosis
- Record updated
- 4 June 2026