The Effect of a Personalized Protein- and Energy-optimized Diet on Muscle Strength in Adult Patients With Chronic Liver Disease

NCT07625085 | Completed

• 1 other identifier: 0057/2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Nutrition; Muscle Strength; Diet; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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.

Interventions

Individualized diet OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients who were clinically stable at the time of enrolment.
• Child-Turcotte-Pugh (CTP) score ≤ 10.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Policlinico Umberto I

Rome, Lazio, 00185, Italy

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 4, 2026
• Study Start: March 7, 2023
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

IT (1)