NCT02931812

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

6 years

First QC Date

October 3, 2016

Last Update Submit

October 7, 2019

Conditions

Keywords

cirrhosisreward systemtaste sensitivitychronic renal failure

Outcome Measures

Primary Outcomes (4)

  • Energy expenditure

    evice: indirect calorimetry (sensormedics)

    two years

  • body composition

    Device: Multifrequency bio-impedancemetry (aminostats)

    2 years

  • amino acids profil in plasma

    Biological measurments

    2 years

  • Food preferences

    Device: Treshold taste detection

    2 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • written consent
  • patients in waiting renal transplant
  • patients in waiting liver transplant

You may not qualify if:

  • chronic infection
  • acute infection
  • cancer
  • antibiotic treatments
  • alcool abuse
  • pregnant woman
  • specific or restrictive diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Taste and Feeding Behaviour

Dijon, Burgundy, 21000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for hormones measurments (leptine, ghrelin, insulin) and plasmatic amino-acids

MeSH Terms

Conditions

FibrosisFood PreferencesTaste DisordersProtein-Energy MalnutritionKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsFeeding BehaviorBehaviorSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsProtein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Central Study Contacts

Laurent Brondel, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 13, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2020

Study Completion

December 1, 2022

Last Updated

October 8, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations