Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients (GREFFE)
Primary Purpose
Eating Behaviour, Liver Transplant
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory quotient
Olfactory liking
Sponsored by
About this trial
This is an interventional other trial for Eating Behaviour
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
liver transplant
kidney transplant
control
stable liver damage
Arm Description
Outcomes
Primary Outcome Measures
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
Change in olfactory liking compared with baseline values by questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02859506
First Posted
August 4, 2016
Last Updated
August 14, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02859506
Brief Title
Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
Acronym
GREFFE
Official Title
Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2015 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Behaviour, Liver Transplant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
liver transplant
Arm Type
Experimental
Arm Title
kidney transplant
Arm Type
Active Comparator
Arm Title
control
Arm Type
Placebo Comparator
Arm Title
stable liver damage
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Respiratory quotient
Intervention Type
Other
Intervention Name(s)
Olfactory liking
Primary Outcome Measure Information:
Title
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
Time Frame
At month 0, month 3, month 6 and month 9
Title
Change in olfactory liking compared with baseline values by questionnaire
Time Frame
At month 0, month 3, month 6 and month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BRONDEL
Phone
03.80.29.34.84
Ext
+33
Email
laurent.brondel@chu-dijon.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BRONDEL
Phone
06 77 10 86 53
Ext
33
Email
laurent.brondel@u-bourgogne.fr
12. IPD Sharing Statement
Learn more about this trial
Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
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