Nutrition and Exercise Prehabilitation in Patients Awaiting Liver Transplantation

Sponsor
Kalliopi Anna Poulia
Study ID
NCT07561138
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 1, 2026
Start date
Jan 8, 2026
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Diet with even protein distribution plus exercise program
  • Experimental: Diet with skewed protein distribution plus exercise program
  • Active Comparator: Standard dietary and physical activity advice

Primary Outcome Measure

Changes in Global Leadership Initiative on Malnutrition (GLIM)-defined malnutrition [ Time Frame: Baseline, 12 weeks ]

Central Contacts

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