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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
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eating Behaviour

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 4, 2016
Last Updated
August 14, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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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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