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Trial record 22 of 84 for:    Taste Disorders AND sense

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

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ClinicalTrials.gov Identifier: NCT02931812
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Laurent BRONDEL, University of Burgundy

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

Condition or disease
Cirrhosis Food Preferences Taste Disorders Protein-Energy Malnutrition Chronic Renal Failure

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.


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Study Type : Observational
Estimated 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 2014
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : December 2019


Group/Cohort
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



Primary Outcome Measures :
  1. Energy expenditure [ Time Frame: two years ]
    evice: indirect calorimetry (sensormedics)

  2. body composition [ Time Frame: 2 years ]
    Device: Multifrequency bio-impedancemetry (aminostats)

  3. amino acids profil in plasma [ Time Frame: 2 years ]
    Biological measurments

  4. Food preferences [ Time Frame: 2 years ]
    Device: Treshold taste detection


Biospecimen Retention:   Samples Without DNA
Blood samples for hormones measurments (leptine, ghrelin, insulin) and plasmatic amino-acids


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 15 patients waiting for renal transplantation
  • 15 patients waiting for liver transplantation
  • 30 healthy subjects matched for gender, age and body mass index
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931812


Contacts
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Contact: Laurent Brondel, Professor 03 80 29 34 84 laurent.brondel@u-bourgogne.fr

Locations
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France
Center for Taste and Feeding Behaviour Recruiting
Dijon, Burgundy, France, 21000
Contact: Laurent Brondel, Professor    03.80.29.34.84    laurent.brondel@u-bourgogne.fr   
Sponsors and Collaborators
University of Burgundy

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Responsible Party: Laurent BRONDEL, Professor, University of Burgundy
ClinicalTrials.gov Identifier: NCT02931812     History of Changes
Other Study ID Numbers: 2014-A00254-43
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Laurent BRONDEL, University of Burgundy:
cirrhosis
reward system
taste sensitivity
chronic renal failure
Additional relevant MeSH terms:
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Taste Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases
Nutrition Disorders
Deficiency Diseases
Sensation Disorders
Nervous System Diseases
Renal Insufficiency
Kidney Failure, Chronic
Malnutrition
Protein-Energy Malnutrition
Hypersensitivity
Fibrosis
Pathologic Processes
Renal Insufficiency, Chronic
Protein Deficiency
Neurologic Manifestations
Signs and Symptoms