FragilityLFI-PATHNCT06911619
Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
A study testing Dietary management and No dietary management in people with Fragility and Cirrhosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cirrhosis is a major public health issue responsible for about 15000 deaths each year. Liver transplantation (LT) remains the only curative treatment for decompensated cirrhosis. Decompensated cirrhotic patients awaiting LT are malnourished, sarcopenic and fragile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fragility, Cirrhosis, Hepatic Transplantation
- What is being tested?
- Dietary management and No dietary management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2025to 30 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse / GHN
Lyon, 69004
Maxime PATUREL, Diététicien, FF CDS, +33 (0)4 72 07 25 43, maxime.paturel@chu-lyon.fr
About this study
Cirrhosis is a major public health issue responsible for about 15000 deaths each year. Liver transplantation (LT) remains the only curative treatment for decompensated cirrhosis. Decompensated cirrhotic patients awaiting LT are malnourished, sarcopenic and fragile. The evaluation of the nutritional status of these patients is complex because the anthropometric data that define undernutrition (weight variation, BMI) are often compromised by the presence of edema and ascites related to liver disease. It therefore seems appropriate to focus on the fragility and sarcopenia of the cirrhotic patient as a reflection of the nutritional status. In 2017, the American team of Lai et al. validated a Liver fraily index (LFI) score of frailty specific to cirrhotic patients waiting for LT. The LFI is composed of three simple physical tests (Grip test, chair lift test, and balance tests) performed at the patient's bedside, which results in a quantitative and reproducible frailty score. Frailty while waiting for LT is associated with an increase in mortality on the waiting list, independently of the MELD (Model for End stage Liver disease) score, which is a reflection of liver severity. About half of the patients who are candidates for LT will present an aggravation of their frailty while waiting for LT. To date, no study has reported the results of a nutritional intervention on the evolution of fragility in patients awaiting LT. The objective of our study is to evaluate the impact of a nutritional management and follow-up by a dietitian specialized in hepatology on the fragility of patients waiting for LT. This is a monocentric study, randomized in two parallel groups (an intervention group with nutritional follow-ups by a trained dietitian and a control group with follow-up by the reference hepatologist without specific dietary management by a dietician) in open. All patients enrolled on the LT list with an LFI > 3.2 (pre-frail and frail state) will be included in the study. It is planned to include 210 patients over a period of 24 months. The LFI will be measured for all patients (control group + intervention group) at 3 and 6 months, as part of their follow-up in the LT center. This study will also make it possible to correlate frailty with other parameters (severity of liver disease, access to LT).
- Conditions
- Fragility, Cirrhosis, Hepatic Transplantation, Undernutrition
- Being tested
- Dietary management, No dietary management
- Keywords
- nutrition, Hepatic Transplantation, Cirrhosis
- Medical subject headings
- Fibrosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary managementDietary supplement
The intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy every month. Follow-up visits in person, carried out by the dietitian at the 3rd and 6th month waiting for transplant and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (CNO, enteral or parenteral nutrition)
No dietary managementOther
Also called Liver Frailty Index
The patient will be followed up by his reference hepatologist every 3 months. Follow-up visits at 3 months and 6 months waiting for liver transplantation will be performed by Clinical Research assistant on the same day as the follow-up consultation with his hepatologist with the completion of the Liver Frailty Index test and the collection of intercurrent events and the reassessment of liver disease.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention Group | Experimental | The intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy. Follow-up visits in person, carried out by the dietician at the 3rd and 6th month waiting for liver transplantation and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (oral nutritional supplement, enteral or parenteral nutrition) Receives: Dietary Supplement: Dietary management |
| Standard Follow up | Other | The patient will be followed up by his referee hepatologist every 3 months. The 3-month and 6-month follow-up visits pending transplantation will be performed with a Clinical Research Assistant on the same day as the follow-up consultation with his hepatologist with the completion of the LFI test and the collection of intercurrent events and the re-evaluation of the liver disease. Receives: Other: No dietary management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact at 3 months, of a nutritional management and follow-up by a dietitian specialized in hepatology compared to the usual management without dietary follow-up, on the fragility of patients waiting for liver transplantation (LT).
Measurement of LFI (Liver fraily index) score score variation between D0 (baseline = visit 1) and 3 months (first reassessment = visit 2) during the liver transplantation waiting period. This variation will be compared between the intervention group and the control group.
Measured: 3rd month after visit 1.
Secondary outcomes (8)
Evaluate the impact of a nutritional follow-up on the fragility of patients at 6 months on list
For patients still on the liver transplantation waiting list, comparison between the intervention and control group of the LFI (Liver fraily index) variation between Baseline (visit 1) and month 6 (visit 3).
Measured: 6th Month after visit 1.
Evaluate the impact of a nutritional follow-up on the distribution of patients' frailty according to classes: robust, pre-fragile, fragile
Compare the evolution of the fragility profile (Robust - Prefragile - Fragile) of patients waiting for liver transplantation according to LFI (Liver fraily index) at M3 and M6 in the intervention group and in the control, group compared with the initial LFI (D0)
Measured: 3rd Month (M3) after Visit 1 and M6 after V1
Evaluate compliance with oral nutritional supplement treatment for patients awaiting transplant
At each follow-up visit (M3 and M6) assessment of compliance with oral nutritional supplements for patients who were prescribed oral nutritional supplements, through questioning their intake: 0, 1⁄4, 1⁄2, 3⁄4 or all of the oral nutritional supplements consumed compared to the prescription.
Measured: 3rd Month and 6th month after Visit 1
Evaluate the relationship between fragility and severity of liver disease (MELD score)
Measure the correlation between LFI (Liver fraily index) at Day 0, M3 and M6 and the severity of liver disease (MELD score),
Measured: Day 0, 3rd Month (M3) and 6th Month (M6)
Evaluate the relationship between fragility and access to a transplant
Measure the correlation between the LFI (Liver fraily index) score at Day 0, Month 3 and Month 6 and access to the transplant
Measured: Day 0, Month 3 after Visit 1, Month 6 after Visit 1
Evaluate the relationship between fragility and mortality on waiting list of transplantation or leaving the list due to worsening
Measure the correlation between LFI (Liver fraily index) score at Day0, M3 and M6 and on-list mortality or leaving the list due to worsening
Measured: Day 0, 3rd month and 6th month
Evaluate the relationship between frailty and unscheduled hospitalizations while waiting for Liver Transplantation
Measure the correlation with the LFI (Liver fraily index) score on Day 0, M3 and M6 and unscheduled hospitalizations awaiting transplant: numbers and indications (infections, encephalopathy, hemorrhage, etc.)
Measured: Day 0, 3rd month and 6th month after Visit 1
Evaluate the satisfaction of dieticians in carrying out nutritional monitoring for patients waiting for liver transplantation (logistics of organizing consultations and teleconsultations)
Evaluate the satisfaction of dieticians in carrying out nutritional monitoring for patients waiting for Liver Transplantation (logistics of organizing consultations and teleconsultations) via questionnary
Measured: study completion at Month 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FragilityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Model description
- Prospective interventional, single-center, randomized, longitudinal study
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime PATUREL, Principal investigator, Service Rééducation Nutritionnelle Hôpital de la Croix Rousse / GHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911619
- Sponsor's protocol ID
- 69HCL24_1201
- Acronym
- LFI-PATH
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Management on the Frailty of Patients Waiting for Liver Transplantation (Via the LFI Tool)
- ClinicalTrials.gov ID
- NCT06911619
- Acronym / sponsor ID
- LFI-PATH / 69HCL24_1201
- Conditions
- Fragility, Cirrhosis, Hepatic Transplantation, Undernutrition
- Keywords
- nutrition, Hepatic Transplantation, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
Cirrhosis is a major public health issue responsible for about 15000 deaths each year. Liver transplantation (LT) remains the only curative treatment for decompensated cirrhosis. Decompensated cirrhotic patients awaiting LT are malnourished, sarcopenic and fragile. The evaluation of the nutritional status of these patients is complex because the anthropometric data that define undernutrition (weight variation, BMI) are often compromised by the presence of edema and ascites related to liver disease. It therefore seems appropriate to focus on the fragility and sarcopenia of the cirrhotic patient as a reflection of the nutritional status. In 2017, the American team of Lai et al. validated a Liver fraily index (LFI) score of frailty specific to cirrhotic patients waiting for LT. The LFI is composed of three simple physical tests (Grip test, chair lift test, and balance tests) performed at the patient's bedside, which results in a quantitative and reproducible frailty score. Frailty while waiting for LT is associated with an increase in mortality on the waiting list, independently of the MELD (Model for End stage Liver disease) score, which is a reflection of liver severity. About half of the patients who are candidates for LT will present an aggravation of their frailty while waiting for LT. To date, no study has reported the results of a nutritional intervention on the evolution of fragility in patients awaiting LT. The objective of our study is to evaluate the impact of a nutritional management and follow-up by a dietitian specialized in hepatology on the fragility of patients waiting for LT. This is a monocentric study, randomized in two parallel groups (an intervention group with nutritional follow-ups by a trained dietitian and a control group with follow-up by the reference hepatologist without specific dietary management by a dietician) in open. All patients enrolled on the LT list with an LFI > 3.2 (pre-frail and frail state) will be included in the study. It is planned to include 210 patients over a period of 24 months. The LFI will be measured for all patients (control group + intervention group) at 3 and 6 months, as part of their follow-up in the LT center. This study will also make it possible to correlate frailty with other parameters (severity of liver disease, access to LT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective interventional, single-center, randomized, longitudinal study
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention Group | Experimental | Dietary Supplement: Dietary managementThe intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy. Follow-up visits in person, carried out by the dietician at the 3rd and 6th month waiting for liver transplantation and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (oral nutritional supplement, enteral or parenteral nutrition) |
| Standard Follow up | Other | Other: No dietary managementThe patient will be followed up by his referee hepatologist every 3 months. The 3-month and 6-month follow-up visits pending transplantation will be performed with a Clinical Research Assistant on the same day as the follow-up consultation with his hepatologist with the completion of the LFI test and the collection of intercurrent events and the re-evaluation of the liver disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Dietary managementThe intervention consists of a personalized dietary management with a nutritional follow-up pending transplantation. Teleconsultation appointments are scheduled with the dietician for dietary coaching and a re-evaluation of the nutritional strategy every month. Follow-up visits in person, carried out by the dietitian at the 3rd and 6th month waiting for transplant and are coupled with the usual consultations with the referring hepatologist. The visits allow the realization of LFI (Liver Frailty Index), the collection of interrelated events and the reassessment of hepatic disease as well as the re-evaluation of the nutritional strategy (CNO, enteral or parenteral nutrition) | Dietary supplement | Dietary intervention Group |
| No dietary managementAlso: Liver Frailty IndexThe patient will be followed up by his reference hepatologist every 3 months. Follow-up visits at 3 months and 6 months waiting for liver transplantation will be performed by Clinical Research assistant on the same day as the follow-up consultation with his hepatologist with the completion of the Liver Frailty Index test and the collection of intercurrent events and the reassessment of liver disease. | Other | Standard Follow up |
Primary outcome
Evaluate the impact at 3 months, of a nutritional management and follow-up by a dietitian specialized in hepatology compared to the usual management without dietary follow-up, on the fragility of patients waiting for liver transplantation (LT).
Time frame: 3rd month after visit 1.
Measurement of LFI (Liver fraily index) score score variation between D0 (baseline = visit 1) and 3 months (first reassessment = visit 2) during the liver transplantation waiting period. This variation will be compared between the intervention group and the control group.
8 secondary outcomes
Evaluate the impact of a nutritional follow-up on the fragility of patients at 6 months on list
Time frame: 6th Month after visit 1.
Evaluate the impact of a nutritional follow-up on the distribution of patients' frailty according to classes: robust, pre-fragile, fragile
Time frame: 3rd Month (M3) after Visit 1 and M6 after V1
Evaluate compliance with oral nutritional supplement treatment for patients awaiting transplant
Time frame: 3rd Month and 6th month after Visit 1
Evaluate the relationship between fragility and severity of liver disease (MELD score)
Time frame: Day 0, 3rd Month (M3) and 6th Month (M6)
Evaluate the relationship between fragility and access to a transplant
Time frame: Day 0, Month 3 after Visit 1, Month 6 after Visit 1
Evaluate the relationship between fragility and mortality on waiting list of transplantation or leaving the list due to worsening
Time frame: Day 0, 3rd month and 6th month
Evaluate the relationship between frailty and unscheduled hospitalizations while waiting for Liver Transplantation
Time frame: Day 0, 3rd month and 6th month after Visit 1
Evaluate the satisfaction of dieticians in carrying out nutritional monitoring for patients waiting for liver transplantation (logistics of organizing consultations and teleconsultations)
Time frame: study completion at Month 30
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 4 Jul 2025.
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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.
Maxime PATUREL principal investigator
Service Rééducation Nutritionnelle Hôpital de la Croix Rousse / GHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary management and No dietary management in people with Fragility and Cirrhosis, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 10 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Maxime PATUREL, Diététicien, FF CDS (+33 (0)4 72 07 25 43, maxime.paturel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact at 3 months, of a nutritional management and follow-up by a dietitian specialized in hepatology compared to the usual management without dietary follow-up, on the fragility of patients waiting for liver transplantation (LT). (time frame: 3rd month after visit 1.). 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 4 Jul 2025.