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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02859506
Other study ID # BRONDEL INRA 2013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2015
Est. completion date December 13, 2019

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date December 13, 2019
Est. primary completion date December 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Respiratory quotient

Olfactory liking


Locations

Country Name City State
France Centre Hospitalier Universitaire Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values At month 0, month 3, month 9 and month 15
Primary Change in olfactory liking compared with baseline values by questionnaire At month 0, month 3, month 9 and month 15
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