Nutritional program to reduce frailty in people waiting for a liver transplant
Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
This trial will try a targeted nutritional management program to see if it reduces frailty in adults with cirrhosis who are on the liver transplant waiting list.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06911619 on ClinicalTrials.gov |
What this trial studies
Adults listed for liver transplantation at Hospices Civils de Lyon who are frail or sarcopenic will be offered a dietary management intervention versus usual care. Frailty will be measured using the Liver Frailty Index (LFI), which combines bedside grip strength, chair stand, and balance tests to produce a reproducible score. Participants with an initial LFI below the frailty threshold are excluded and those unable to perform the physical tests are not eligible. The trial compares change in frailty and nutritional status between the dietary management group and the no-dietary-management group during the pre-transplant waiting period.
Who should consider this trial
Good fit: Adults (≥18) who are registered on the liver transplant waiting list at Croix Rousse Hospital with cirrhosis and an LFI indicating frailty (LFI ≥ 3.2), who can perform the physical tests and provide informed consent, are ideal candidates.
Not a fit: Patients with an initial LFI indicating robustness (LFI < 3.2), those unable to perform the LFI exercises, patients in intensive care, pregnant or lactating women, or those under legal/psychiatric restrictions are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, the nutritional program could reduce frailty and sarcopenia before transplant, potentially lowering complications and improving transplant outcomes.
How similar studies have performed: The Liver Frailty Index was validated by Lai et al. in 2017 for measuring frailty in transplant candidates, but evidence that nutrition interventions reliably reverse frailty in cirrhosis is limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged ≥ 18 years * Patient registered on the waiting list for Hepatic Transplantation in the Transplantation center of the Croix Rousse Hospital (GHN), Hospices Civils de Lyon * Dated and signed an informed consent * Affiliated to a social security scheme or beneficiary of a similar scheme Exclusion Criteria: * Patient hospitalized in intensive care * Patient with initial LFI test result \< to 3.2, that is considered as "robust". * Patient unable to perform LFI exercises (chronic or acute motor disability in lower or upper limbs) * Pregnant, parturient or lactating women * Persons deprived of liberty by a judicial or administrative decision * Persons under psychiatric care * Persons admitted to a health or social institution for purposes other than research * Adults subject to a legal protection measure (guardianship, curatorship) * Inability to understand protocol information * Subject participating in another interventional research including an ongoing exclusion period at inclusion
Where this trial is running
Lyon
- Hôpital de la Croix Rousse / GHN — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Maxime PATUREL — Service Rééducation Nutritionnelle Hôpital de la Croix Rousse / GHN
- Study coordinator: Maxime PATUREL, Diététicien, FF CDS
- Email: maxime.paturel@chu-lyon.fr
- Phone: +33 (0)4 72 07 25 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.