Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
GREFFE
1 other identifier
interventional
73
1 country
1
Brief Summary
Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis. The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedFebruary 22, 2024
February 1, 2024
4.4 years
August 4, 2016
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
At month 0, month 3, month 9 and month 15
Change in olfactory liking compared with baseline values by questionnaire
At month 0, month 3, month 9 and month 15
Study Arms (4)
liver transplant
EXPERIMENTALkidney transplant
ACTIVE COMPARATORcontrol
PLACEBO COMPARATORstable liver damage
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- persons who have provided written informed consent
- persons aged between 18 and 70 years
- persons waiting for a liver transplantation (group LT)
- persons with stable liver damage
- persons waiting for a kidney transplantation (KT)
- healthy subjects (control group) no known disease
You may not qualify if:
- persons without national health insurance cover
- persons with chronic infection,
- persons with acute infection,
- persons with progressive cancer,
- persons with an antibiotic treatment,
- persons who drink alcohol,
- pregnant or breast-feeding women,
- persons with an aversion to the foods proposed in the study,
- persons taking treatments known to interfere with gustatory and olfactory performance,
- adults under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire
Dijon, 21079, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 9, 2016
Study Start
July 3, 2015
Primary Completion
December 13, 2019
Study Completion
December 13, 2019
Last Updated
February 22, 2024
Record last verified: 2024-02