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

Sponsor
University of Burgundy (Other)
Overall Status
Recruiting
CT.gov ID
NCT02931812
Collaborator
(none)
60
1
103
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Study Details

Study Description

Brief 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

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
Study Start Date :
May 1, 2014
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Cirrhotic subjects

15 cirrhotic patients in end-stage in waiting a graft

Chronic kidney disease subjects

15 chronic kidney disease patients in end-stage in waiting a graft

Healthy subjects

30 healthy subjects to compare

Outcome Measures

Primary Outcome Measures

  1. Energy expenditure [two years]

    evice: indirect calorimetry (sensormedics)

  2. body composition [2 years]

    Device: Multifrequency bio-impedancemetry (aminostats)

  3. amino acids profil in plasma [2 years]

    Biological measurments

  4. Food preferences [2 years]

    Device: Treshold taste detection

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Taste and Feeding Behaviour Dijon Burgundy France 21000

Sponsors and Collaborators

  • University of Burgundy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laurent BRONDEL, Professor, University of Burgundy
ClinicalTrials.gov Identifier:
NCT02931812
Other Study ID Numbers:
  • 2014-A00254-43
First Posted:
Oct 13, 2016
Last Update Posted:
Oct 8, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Laurent BRONDEL, Professor, University of Burgundy
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2019