Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation

Cirrhosis Clinical Trial

— GREFFE  

Official title:

Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02931812
• Other study ID #: 2014-A00254-43
• Status: Recruiting
• Start date: May 2014
• Est. completion date: December 2022

Study information

• Verified date: October 2019
• Source: University of Burgundy
• Contact: Laurent Brondel, Professor
• Phone: 03 80 29 34 84
• Email: laurent.brondel[@]u-bourgogne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the influence of the taste sensitivity, of food preferences and of the reward system on the energetic balance before and after liver transplantation in cirrhotic patients and after kidney transplantation in renal failure patients

Description:

Background and Aims: Protein-energy malnutrition is associated to cirrhosis with a high prevalence and greatly increases the morbidity and mortality of the disease. Malnutrition results of numerous causes including intestinal malabsorption, increased energy resting expenditure, metabolism disturbances, impaired sensory taste and changes in food preferences which might participate to a reduction in food intake. The aim of this study was to determine the relationships that may exist between taste sensitivity and food preferences on the one hand, eating habits, nutritional status, energy balance and biological parameters including amino acids on the other hand in patients with end-stage cirrhosis and in patients with renal failure.

Fifteen end-stage cirrhotic patients and 15 renal failure patients will be included and matched with 30 healthy subjects. The following parameters will be evaluated during a morning testing session: gustatory sensitivity using a triangular detection threshold method for sweet, salty and umami solutions; preferences for fat- and carbohydrate-rich foods using the PrefQuest score; liking for six foods (protein-, carbohydrate- and fat-rich foods) and wanting for 18 foods (photographs); hunger sensation; energy intake (24 h ingested food); body composition (BMI and impedancemetry); resting energy expenditure (indirect calorimetry) and physical activity (questionnaire). Several plasmatic parameters (amino-acids, leptin, ghrelin, lipid profile) will be also determined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• written consent

• patients in waiting renal transplant

• patients in waiting liver transplant

Exclusion Criteria:

• chronic infection

• acute infection

• cancer

• antibiotic treatments

• alcool abuse

• pregnant woman

• specific or restrictive diet

Related Conditions & MeSH terms

• Chronic Renal Failure
• Cirrhosis
• Fibrosis
• Food Preferences
• Hypersensitivity
• Kidney Failure, Chronic
• Malnutrition
• Protein-Energy Malnutrition
• Renal Insufficiency
• Taste Disorders

Locations

Country	Name	City	State
France	Center for Taste and Feeding Behaviour	Dijon	Burgundy

Sponsors (1)

Lead Sponsor	Collaborator
University of Burgundy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure	evice: indirect calorimetry (sensormedics)	two years
Primary	body composition	Device: Multifrequency bio-impedancemetry (aminostats)	2 years
Primary	amino acids profil in plasma	Biological measurments	2 years
Primary	Food preferences	Device: Treshold taste detection	2 years