GREFFE: Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT02859506

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Behaviour Liver Transplant	Other: Respiratory quotient Other: Olfactory liking	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients

Actual Study Start Date :

Jul 3, 2015

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: liver transplant	Other: Respiratory quotient Other: Olfactory liking
Active Comparator: kidney transplant	Other: Respiratory quotient Other: Olfactory liking
Placebo Comparator: control	Other: Respiratory quotient Other: Olfactory liking
Active Comparator: stable liver damage	Other: Respiratory quotient Other: Olfactory liking

Outcome Measures

Primary Outcome Measures

Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values [At month 0, month 3, month 6 and month 9]
Change in olfactory liking compared with baseline values by questionnaire [At month 0, month 3, month 6 and month 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02859506

Other Study ID Numbers:

BRONDEL INRA 2013

First Posted:

Aug 9, 2016

Last Update Posted:

Aug 16, 2019

Last Verified:

Aug 1, 2019

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Aug 16, 2019