Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation

NCT07561138 | Recruiting

• 1 other identifier: 113/05.12.2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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 awaiting liver transplantation.

Conditions

Liver Cirrhosis; Malnutrition; Sarcopenia; Frailty; End-stage Liver Disease; Liver Transplantation

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Baseline, 12 weeks

Secondary Outcomes (34)

• Nutritional Risk Screening-2002 (NRS-2002)-derived nutritional risk

  Baseline

• Malnutrition Screening Tool (MST)-derived nutritional risk

  Baseline

• Malnutrition Universal Screening Tool (MUST)-derived nutritional risk

  Baseline

• Short Nutritional Assessment Questionnaire (SNAQ)-derived nutritional risk

  Baseline

• Mini Nutritional Assessment-Short Form (MNA-SF)-derived nutritional status

  Baseline

Other Outcomes (27)

• Adherence to the program

  4 weeks, 8 weeks, 12 weeks

• Satisfaction with the program

  12 weeks

• Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition

  3 months post-transplantation

Study Arms (3)

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

Interventions

Diet with even protein distribution plus exercise program BEHAVIORAL

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 even protein distribution plus exercise program

Diet with skewed protein distribution plus exercise program BEHAVIORAL

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

Diet with skewed protein distribution plus exercise program

Standard dietary and physical activity advice BEHAVIORAL

Standard dietary and physical activity advice \| Duration: 12 weeks

Standard dietary and physical activity advice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laikο General Hospital, Athens: collaborator
• Kalliopi Anna Poulia: lead

Study Sites (2)

Laiko General Hospital of Athens

Athens, Attica, 11527, Greece

RECRUITING

Agricultural University of Athens

Athens, Attica, 11855, Greece

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Liver Cirrhosis; Malnutrition; Sarcopenia; Frailty; Liver Diseases; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Kalliopi Anna Poulia

CONTACT

+30 2105294668; lpoulia@aua.gr

Evangelos Cholongitas

CONTACT

+30 2132061643; echolog@med.uoa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 1, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)