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

February 21, 2024 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21079
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
Time Frame: At month 0, month 3, month 9 and month 15
At month 0, month 3, month 9 and month 15
Change in olfactory liking compared with baseline values by questionnaire
Time Frame: At month 0, month 3, month 9 and month 15
At month 0, month 3, month 9 and month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2015

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimated)

August 9, 2016

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRONDEL INRA 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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