End-stage Liver DiseasePOWER-LTNCT07561138
Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation
A study testing Diet with even protein distribution plus exercise program, Diet with skewed protein distribution plus exercise program and Standard dietary and physical activity advice in people with End-stage Liver Disease and Liver Cirrhosis, run by Kalliopi Anna Poulia at 2 sites in Greece.
Trial summary
This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-stage Liver Disease, Liver Cirrhosis, Liver Transplantation
- What is being tested?
- Diet with even protein distribution plus exercise program, Diet with skewed protein distribution plus exercise program and Standard dietary and physical activity advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGreece
- Study dates
- 8 Jan 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture
- Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation
- No prior formal dietary advice
Who cannot join
- Age < 18 years old
- Estimated waiting time for liver transplantation < 3 months
- Estimated life expectancy < 3 months
- Chronic kidney disease requiring protein restriction
- Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)
- Unstable or severe psychiatric disorder
- Pregnancy or lactation
- Inability to provide written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Laiko General Hospital of Athens
Athens, Attica, 11527
Evangelos Cholongitas, +30 2132061643, echolog@med.uoa.gr
- Recruiting
Agricultural University of Athens
Athens, Attica, 11855
Kalliopi Anna Poulia, +30 2105294668, lpoulia@aua.gr
About this study
Official title: Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial
This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.
Read the detailed description
Malnutrition and sarcopenia affect many patients awaiting liver transplantation and is associated with reduced quality of life and increased mortality. According to the current European Society for Clinical Nutrition and Metabolism (ESPEN) and European Association for the Study of the Liver (EASL) guidelines, a target of 1.2-1.5 g protein per kg body weight daily is recommended for patients with decompensated liver cirrhosis. While evidence supports that even protein distribution enhances muscle protein synthesis in healthy adults, specific protein timing recommendations are lacking for patients with end-stage liver disease.
Therefore, this randomized controlled trial aims to investigate the effects of a 12-week diet with even protein distribution plus exercise (Group A) versus skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C), primarily on nutritional status, body composition and functional status, and secondarily on anthropometric measurements, laboratory parameters, quality of life, disease severity, complications and mortality in liver transplant candidates. Moreover, late postoperative parameters, including length of hospital stay, length of intensive care unit stay, duration of mechanical ventilation, postoperative complications, hospital readmissions, reoperations and mortality will be examined for those who undergo transplantation.
- Conditions
- End-stage Liver Disease, Liver Cirrhosis, Liver Transplantation, Malnutrition, Sarcopenia, Frailty
- Being tested
- Diet with even protein distribution plus exercise program, Diet with skewed protein distribution plus exercise program, Standard dietary and physical activity advice
- Keywords
- liver disease, end-stage liver disease, liver cirrhosis, liver transplantation, malnutrition, sarcopenia, frailty, diet, nutrition, nutrition therapy, protein, protein distribution, exercise, prehabilitation, nutritional status, body composition, functional status, physical performance, quality of life
- Medical subject headings
- End Stage Liver Disease, Liver Cirrhosis, Malnutrition, Sarcopenia, Frailty, Liver Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet with even protein distribution plus exercise programBehavioural
Diet of 1.2-1.5 g protein/kg dry body weight/day, equally divided (33.3% at 3 main meals) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks
Diet with skewed protein distribution plus exercise programBehavioural
Diet of 1.2-1.5 g protein/kg dry body weight/day, unequally divided (10.0% at breakfast, 60.0% at lunch, 30.0% at dinner) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks
Standard dietary and physical activity adviceBehavioural
Standard dietary and physical activity advice | Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Diet with even protein distribution plus exercise program | Experimental | Not described Receives: Behavioral: Diet with even protein distribution plus exercise program |
| Diet with skewed protein distribution plus exercise program | Experimental | Not described Receives: Behavioral: Diet with skewed protein distribution plus exercise program |
| Standard dietary and physical activity advice | Active comparator | Not described Receives: Behavioral: Standard dietary and physical activity advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition
Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria include: a. Non-votional weight loss (%): > 5% within past 6 months or > 10% beyond 6 months, b. Low body mass index (BMI, kg/m^2): < 20 kg/m^2 if < 70 years or < 22 kg/m^2 if > 70 years, c. Reduced muscle mass, assessed by validated body composition measuring techniques [e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT)]. Etiologic criteria include: a. Reduced food intake or assimillation: ≤ 50% of energy requirements > 1 week or any reduction for > 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption, b. Inflammation: acute disease/injury or chronic disease-related.
Measured: Baseline, 12 weeks
Changes in Computed Tomography (CT)-derived muscle mass
Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm^2/m^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m^2).Thresholds for reduced SMI will be considered < 50 cm^2/m^2 for men and < 39 cm^2/m^2 for women.
Measured: Baseline, 12 weeks
Changes in handgrip strength (kg)
Handgrip strength (kg) will be assessed using a digital handgrip dynamometer. Thresholds for reduced muscle strength will be considered < 27 kg for men and < 16 kg for women.
Measured: Baseline, 12 weeks
Changes in Short Physical Performance Battery (SPPB) score
The Short Physical Performance Battery (SPPB) includes 3 components: 3-positions balance testing (sec) (0-4 points), 4-meter gait speed test (sec) (0-4 points) and 5-times chair stand test (sec) (0-4 points), with a total score of 0-12. Higher scores indicate a better physical performance: 0-3 points for worst physical performance, 4-9 points for reduced physical performance and 10-12 points for best physical performance.
Measured: Baseline, 12 weeks
Changes in Liver Frailty Index
The Liver Frailty Index includes 3 components: handgrip strength (kg), 5-times chair stand test (sec) and 3-positions balance testing (sec). Higher scores indicate a greater degree of frailty.
Measured: Baseline, 12 weeks
Changes in European Working Group on Sarcopenia in Older People 2 (EWGSOP2)-derived sarcopenia
Sarcopenia will be diagnosed using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. Diagnosis requires low muscle strength and low muscle mass. Reduced muscle strength will be diagnozed by: a. Low handgrip strength (kg): > 27 kg for men and > 16 kg for women or b. Low chair stand test (sec): >15 sec for 5-times chair stand test. Reduced muscle mass will be diagnozed by: a. Low Appendicular Skeletal Muscle Mass (ASM, kg): < 20 kg for men and < 15 kg for women or b. Low Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2): <7.0 kg/m^2 for men and < 5.5 kg/m^2 for women.
Measured: Baseline, 12 weeks
Secondary outcomes (34)
Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk
Nutritional risk will be assessed using the Nutritional Risk Screening-2002 (NRS-2002) tool. Higher scores indicate greater nutritional risk: < 3 points indicate good nutritional status and ≥ 3 nutritional risk.
Measured: Baseline
Malnutrition Screening Tool (MST)-derived nutritional risk
Nutritional risk will be assessed using the Malnutrition Screening Tool (MST) tool. Higher scores indicate greater nutritional risk: < 2 points indicate good nutritional status and ≥ 2 nutritional risk.
Measured: Baseline
Malnutrition Universal Screening Tool (MUST)-derived nutritional risk
Nutritional risk will be assessed using the Malnutrition Universal Screening Tool (MUST) tool. Higher scores indicate greater nutritional risk: 0 points indicate low risk, 1 point medium risk and ≥ 2 high risk.
Measured: Baseline
Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk
Nutritional risk will be assessed using the Short Nutritional Assessment Questionnaire (SNAQ) tool. Higher scores indicate greater nutritional risk: 0-1 points indicate low risk, 2 points medium risk and ≥ 3 points high risk.
Measured: Baseline
Mini Nutritional Assessment-Short Form (MNA-SF)-derived nutritional status
Nutritional risk will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF) tool. Lower scores indicate greater nutritional risk: 12-14 points indicate good nutritional status, 8-11 points risk of malnutrition and 0-7 points malnutrition.
Measured: Baseline
Nutritional Risk Index (NRI)-derived nutritional risk
Nutritional risk will be assessed using the Nutritional Risk Index (NRI) tool. Lower scores indicate greater nutritional risk: > 100.0 indicate good nutritional status, 97.5-100.0 low risk, 83.5-97.5 medium risk and < 83.5 high risk.
Measured: Baseline
Prognostic Nutritional Index (PNI)-derived nutritional status
Nutritional risk will be assessed using the Prognostic Nutritional Index (PNI) tool. Lower scores indicate greater nutritional risk: ≥ 50 indicate good nutritional status, < 50 low risk, < 45 medium risk and < 40 high risk.
Measured: Baseline
Controlling Nutritional Status (CONUT)-derived nutritional status
Nutritional risk will be assessed using the Controlling Nutritional Status (CONUT) tool. Higher scores indicate greater nutritional risk: 0-1 points indicate good nutritional status, 2-4 points low risk, 5-8 medium risk and 9-12 high risk.
Measured: Baseline
Liver Disease Undernutrition Screening Tool (LDUST)-derived nutritional risk
Nutritional risk will be assessed using the Liver Disease Undernutrition Screening Tool (LDUST) tool. ≥ 5 answers "A" indicate good nutritional status and ≥ 2 answers "B" and/or "C" malnutrition.
Measured: Baseline
Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT)-derived nutritional status
Nutritional risk will be assessed using the Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT) tool. Higher scores indicate greater nutritional risk: 0 points indicate low risk, 1 point medium risk and 2-7 points high risk.
Measured: Baseline
Dual-Energy X-ray Absorptiometry (DEXA)-derived muscle mass
Muscle mass will be assessed using the Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2) using Dual-Energy X-ray Absorptiometry (DEXA). Thresholds for reduced muscle mass will be considered < 7.0 for men and < 5.4 for women.
Measured: Baseline
Food Frequency Questionnaire (FFQ)-derived dietary habits
Long-term dietary habits will be assessed using a semi-quantitative Food Frequency Questionnaire (FFQ).
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)-derived physical activity levels
Physical activity levels will be assessed using the International Physical Activity Questionnaire (IPAQ)-Short Form. IPAQ includes 7 open-ended questions. Higher scores (MET-min/week) indicate higher physical activity levels.
Measured: Baseline
Changes in Bioelectrical Impedance Analysis (BIA)-derived muscle mass
Muscle mass will be assessed using the Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2) by Bioelectrical Impedance Analysis (BIA). Thresholds for reduced ASMI will be considered < 7.0 for men and < 5.7 for women.
Measured: Baseline, 12 weeks
Changes in body weight (kg)
Body weight (kg) will be measured using a calibrated weight scale.
Measured: Baseline, 12 weeks
Changes in Body Mass Index (BMI, kg/m^2)
Body Mass Index (BMI, kg, m^2) will be calculated by dividing body weight (kg) by height squared (m^2), which will be measured using a calibrated stadiometer.
Measured: Baseline, 12 weeks
Changes in Mid-Arm Muscle Circumference (MAMC, cm)
Mid-Arm Muscle Circumference (MAMC, cm) will be calculated using the following formula: MAMC (cm) = Mid-Arm Circumference (MAC, cm) - [0.314*Triceps Skinfold Thickness (TSF, mm)]. MAC will be measured using a non-stretchable measuring tape and TSF using a calibrated skinfold caliper. Thresholds for reduced MAMC will be considered < 25 cm for men and < 22 cm for women.
Measured: Baseline, 12 weeks
Changes in Bristol Stool Chart
Bowel habits will be assessed using the Bristol Stool Chart. Bristol Stool Chart classifies stool forms in 7 types: types 1-2 indicate constipation, types 3-4 normal stool form, and types 5-7 looser stools tending toward diarrhea
Measured: Baseline, 12 weeks
Changes in Chronic Liver Disease Questionnaire (CLDQ)
Quality of life will be assessed using the Chronic Liver Disease Questionnaire (CLDQ). CLDQ includes 29 items in 6 domains: fatigue, activity, emotional function, abdominal symptoms, systemic symptoms, and worry. Each is scored on a 7-point scale, with higher domain and total scores indicating a better quality of life.
Measured: Baseline, 12 weeks
Changes in aspartate aminotransferase (AST, U/L)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in alanine aminotransferase (ALT, U/L)
Data will be collected through medical chart review
Measured: Baseline, 12 weeks
Changes in alkaline phosphatase (ALP, U/L)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in gamma-glutamyltransferase (GGT, U/L)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in total bilirubin (mg/dL)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in direct bilirubin (mg/dL)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in International Normalized Ratio (INR)
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in MELD-Na score
Data will be collected through medical chart review. Higher MELD-Na scores indicate greater severity of chronic liver disease and higher predictive risk of mortality (< 17 points: <2%, 17-20 points: 3-4%, 21-22 points: 7-10%, 23-26 points: 14-15%, 27-31 points: 27-32%, ≥ 32 points: 65-66%)
Measured: Baseline, 12 weeks
Changes in Child-Pugh score
Data will be collected through medical chart review. Higher Child-Pugh scores indicate greater severity of liver cirrhosis [class A (5-6 points): mild, class B: (7-9 points): moderate, class C (10-15) points: severe]
Measured: Baseline, 12 weeks
Changes in presence of oedema and/or ascites
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in presence of jaundice
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in presence of variceal bleeding
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in presence of infections
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Changes in presence of hepatic encephalopathy
Data will be collected through medical chart review.
Measured: Baseline, 12 weeks
Mortality
Data will be collected through medical chart review.
Measured: From baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start8 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kalliopi Anna Poulia
- Sponsor type
- University, hospital or other
- Collaborators
- Laikο General Hospital, Athens
- Responsible party
- Sponsor-investigator, Kalliopi Anna Poulia, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561138
- Sponsor's protocol ID
- 113/05.12.2025
- Acronym
- POWER-LT
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Protein Distribution Optimization With Exercise Regimen on Nutritional Status, Body Composition and Functional Status in Patients Awaiting Liver Transplantation: The POWER-LT Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07561138
- Acronym / sponsor ID
- POWER-LT / 113/05.12.2025
- Conditions
- End-stage Liver Disease, Liver Cirrhosis, Liver Transplantation, Malnutrition, Sarcopenia, Frailty
- Keywords
- liver disease, end-stage liver disease, liver cirrhosis, liver transplantation, malnutrition, sarcopenia, frailty, diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kalliopi Anna PouliaUniversity, hospital or other
- Collaborators
- Laikο General Hospital, Athens
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of a diet with even protein distribution plus exercise (Group A) versus a diet with skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C) on nutritional status, body composition and functional status in patients awaiting liver transplantation.
Detailed description
Malnutrition and sarcopenia affect many patients awaiting liver transplantation and is associated with reduced quality of life and increased mortality. According to the current European Society for Clinical Nutrition and Metabolism (ESPEN) and European Association for the Study of the Liver (EASL) guidelines, a target of 1.2-1.5 g protein per kg body weight daily is recommended for patients with decompensated liver cirrhosis. While evidence supports that even protein distribution enhances muscle protein synthesis in healthy adults, specific protein timing recommendations are lacking for patients with end-stage liver disease.
Therefore, this randomized controlled trial aims to investigate the effects of a 12-week diet with even protein distribution plus exercise (Group A) versus skewed protein distribution plus exercise (Group B) versus standard dietary and physical activity advice (Group C), primarily on nutritional status, body composition and functional status, and secondarily on anthropometric measurements, laboratory parameters, quality of life, disease severity, complications and mortality in liver transplant candidates. Moreover, late postoperative parameters, including length of hospital stay, length of intensive care unit stay, duration of mechanical ventilation, postoperative complications, hospital readmissions, reoperations and mortality will be examined for those who undergo transplantation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet with even protein distribution plus exercise program | Experimental | Behavioral: Diet with even protein distribution plus exercise program |
| Diet with skewed protein distribution plus exercise program | Experimental | Behavioral: Diet with skewed protein distribution plus exercise program |
| Standard dietary and physical activity advice | Active comparator | Behavioral: Standard dietary and physical activity advice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End-stage liver disease, diagnosed by transient elastography (FibroScan) or imaging-based evaluation with compatible clinical picture
- Referred for liver transplantation and evaluated to have a high likelihood of being listed, according to primary hepatologist assessment, or already listed for liver transplantation
- No prior formal dietary advice
Key exclusion criteria (8 listed)
- Age < 18 years old
- Estimated waiting time for liver transplantation < 3 months
- Estimated life expectancy < 3 months
- Chronic kidney disease requiring protein restriction
- Exercise contraindicated (e.g., active or recent variceal bleeding, severe grade of hepatic encephalopathy, refractory ascites, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet with even protein distribution plus exercise programDiet of 1.2-1.5 g protein/kg dry body weight/day, equally divided (33.3% at 3 main meals) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks | Behavioural | Diet with even protein distribution plus exercise program |
| Diet with skewed protein distribution plus exercise programDiet of 1.2-1.5 g protein/kg dry body weight/day, unequally divided (10.0% at breakfast, 60.0% at lunch, 30.0% at dinner) | Exercise program: 3 days/week aerobic and 2 days/week resistance | Duration: 12 weeks | Behavioural | Diet with skewed protein distribution plus exercise program |
| Standard dietary and physical activity adviceStandard dietary and physical activity advice | Duration: 12 weeks | Behavioural | Standard dietary and physical activity advice |
Primary outcome
Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition
Time frame: Baseline, 12 weeks
Malnutrition will be diagnosed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. Diagnosis requires at least 1 phenotypic criterion and 1 etiologic criterion. Phenotypic criteria include: a. Non-votional weight loss (%): > 5% within past 6 months or > 10% beyond 6 months, b. Low body mass index (BMI, kg/m^2): < 20 kg/m^2 if < 70 years or < 22 kg/m^2 if > 70 years, c. Reduced muscle mass, assessed by validated body composition measuring techniques [e.g. Dual-Energy X-ray Absorptiometry (DEXA), Bioelectrical Impedance Analysis (BIA) or Computed Tomography (CT)]. Etiologic criteria include: a. Reduced food intake or assimillation: ≤ 50% of energy requirements > 1 week or any reduction for > 2 weeks or any chronic gastrointestinal condition that adversely impacts food assimilation or absorption, b. Inflammation: acute disease/injury or chronic disease-related.
Changes in Computed Tomography (CT)-derived muscle mass
Time frame: Baseline, 12 weeks
Muscle mass will be assessed using the Skeletal Muscle Index (SMI, cm^2/m^2). SMI will be calculated by measuring the total cross-sectional area of skeletal muscles, from a single cross-sectional Computed Tomography (CT) image at L3 vertebral level, using Hounsfield Units of -29 to +150 HU, and normalizing to height squared (m^2).Thresholds for reduced SMI will be considered < 50 cm^2/m^2 for men and < 39 cm^2/m^2 for women.
Changes in handgrip strength (kg)
Time frame: Baseline, 12 weeks
Handgrip strength (kg) will be assessed using a digital handgrip dynamometer. Thresholds for reduced muscle strength will be considered < 27 kg for men and < 16 kg for women.
Changes in Short Physical Performance Battery (SPPB) score
Time frame: Baseline, 12 weeks
The Short Physical Performance Battery (SPPB) includes 3 components: 3-positions balance testing (sec) (0-4 points), 4-meter gait speed test (sec) (0-4 points) and 5-times chair stand test (sec) (0-4 points), with a total score of 0-12. Higher scores indicate a better physical performance: 0-3 points for worst physical performance, 4-9 points for reduced physical performance and 10-12 points for best physical performance.
Changes in Liver Frailty Index
Time frame: Baseline, 12 weeks
The Liver Frailty Index includes 3 components: handgrip strength (kg), 5-times chair stand test (sec) and 3-positions balance testing (sec). Higher scores indicate a greater degree of frailty.
Changes in European Working Group on Sarcopenia in Older People 2 (EWGSOP2)-derived sarcopenia
Time frame: Baseline, 12 weeks
Sarcopenia will be diagnosed using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. Diagnosis requires low muscle strength and low muscle mass. Reduced muscle strength will be diagnozed by: a. Low handgrip strength (kg): > 27 kg for men and > 16 kg for women or b. Low chair stand test (sec): >15 sec for 5-times chair stand test. Reduced muscle mass will be diagnozed by: a. Low Appendicular Skeletal Muscle Mass (ASM, kg): < 20 kg for men and < 15 kg for women or b. Low Appendicular Skeletal Muscle Mass Index (ASMI, kg/m^2): <7.0 kg/m^2 for men and < 5.5 kg/m^2 for women.
34 secondary outcomes
Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk
Time frame: Baseline
Malnutrition Screening Tool (MST)-derived nutritional risk
Time frame: Baseline
Malnutrition Universal Screening Tool (MUST)-derived nutritional risk
Time frame: Baseline
Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk
Time frame: Baseline
Mini Nutritional Assessment-Short Form (MNA-SF)-derived nutritional status
Time frame: Baseline
Nutritional Risk Index (NRI)-derived nutritional risk
Time frame: Baseline
Prognostic Nutritional Index (PNI)-derived nutritional status
Time frame: Baseline
Controlling Nutritional Status (CONUT)-derived nutritional status
Time frame: Baseline
Liver Disease Undernutrition Screening Tool (LDUST)-derived nutritional risk
Time frame: Baseline
Royal Free Hospital-Nutritional Prioritizing Tool (RHT-NPT)-derived nutritional status
Time frame: Baseline
Dual-Energy X-ray Absorptiometry (DEXA)-derived muscle mass
Time frame: Baseline
Food Frequency Questionnaire (FFQ)-derived dietary habits
Time frame: Baseline
International Physical Activity Questionnaire (IPAQ)-derived physical activity levels
Time frame: Baseline
Changes in Bioelectrical Impedance Analysis (BIA)-derived muscle mass
Time frame: Baseline, 12 weeks
Changes in body weight (kg)
Time frame: Baseline, 12 weeks
Changes in Body Mass Index (BMI, kg/m^2)
Time frame: Baseline, 12 weeks
Changes in Mid-Arm Muscle Circumference (MAMC, cm)
Time frame: Baseline, 12 weeks
Changes in Bristol Stool Chart
Time frame: Baseline, 12 weeks
Changes in Chronic Liver Disease Questionnaire (CLDQ)
Time frame: Baseline, 12 weeks
Changes in aspartate aminotransferase (AST, U/L)
Time frame: Baseline, 12 weeks
Changes in alanine aminotransferase (ALT, U/L)
Time frame: Baseline, 12 weeks
Changes in alkaline phosphatase (ALP, U/L)
Time frame: Baseline, 12 weeks
Changes in gamma-glutamyltransferase (GGT, U/L)
Time frame: Baseline, 12 weeks
Changes in total bilirubin (mg/dL)
Time frame: Baseline, 12 weeks
Changes in direct bilirubin (mg/dL)
Time frame: Baseline, 12 weeks
Changes in International Normalized Ratio (INR)
Time frame: Baseline, 12 weeks
Changes in MELD-Na score
Time frame: Baseline, 12 weeks
Changes in Child-Pugh score
Time frame: Baseline, 12 weeks
Changes in presence of oedema and/or ascites
Time frame: Baseline, 12 weeks
Changes in presence of jaundice
Time frame: Baseline, 12 weeks
Changes in presence of variceal bleeding
Time frame: Baseline, 12 weeks
Changes in presence of infections
Time frame: Baseline, 12 weeks
Changes in presence of hepatic encephalopathy
Time frame: Baseline, 12 weeks
Mortality
Time frame: From baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet with even protein distribution plus exercise program, Diet with skewed protein distribution plus exercise program and Standard dietary and physical activity advice in people with End-stage Liver Disease and Liver Cirrhosis, run by Kalliopi Anna Poulia at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kalliopi Anna Poulia (+30 2105294668, lpoulia@aua.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition (time frame: Baseline, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.