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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Other: Individualized diet

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00185
      • Policlinico Umberto I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Individualized 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in handgrip strength (kg) from baseline to Week 16 measured using a Hand Dynamometer	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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition; Diet; Muscle Strength; Liver cirrhosis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis
• Other Study ID Numbers: 0057/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No