CirrhosisGREFFENCT02931812
Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
An observational study of Cirrhosis and Food Preferences, run by University of Burgundy at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Food Preferences, Taste Disorders
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- written consent
- patients in waiting renal transplant
- patients in waiting liver transplant
Who cannot join
- chronic infection
- acute infection
- cancer
- antibiotic treatments
- alcool abuse
- pregnant woman
- specific or restrictive diet
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Center for Taste and Feeding Behaviour
Dijon, Burgundy, 21000
Laurent Brondel, Professor, 03.80.29.34.84, laurent.brondel@u-bourgogne.fr
About this study
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
Read the 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.
- Conditions
- Cirrhosis, Food Preferences, Taste Disorders, Protein-Energy Malnutrition, Chronic Renal Failure
- Keywords
- cirrhosis, reward system, taste sensitivity, chronic renal failure
- Medical subject headings
- Fibrosis, Food Preferences, Taste Disorders, Protein-Energy Malnutrition, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
evice: indirect calorimetry (sensormedics)
Measured: two years
body composition
Device: Multifrequency bio-impedancemetry (aminostats)
Measured: 2 years
amino acids profil in plasma
Biological measurments
Measured: 2 years
Food preferences
Device: Treshold taste detection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent BRONDEL, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931812
- Sponsor's protocol ID
- 2014-A00254-43
- Acronym
- GREFFE
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2016
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
- ClinicalTrials.gov ID
- NCT02931812
- Acronym / sponsor ID
- GREFFE / 2014-A00254-43
- Conditions
- Cirrhosis, Food Preferences, Taste Disorders, Protein-Energy Malnutrition, Chronic Renal Failure
- Keywords
- cirrhosis, reward system, taste sensitivity, chronic renal failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- written consent
- patients in waiting renal transplant
- patients in waiting liver transplant
Key exclusion criteria (7 listed)
- chronic infection
- acute infection
- cancer
- antibiotic treatments
- alcool abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Energy expenditure
Time frame: two years
evice: indirect calorimetry (sensormedics)
body composition
Time frame: 2 years
Device: Multifrequency bio-impedancemetry (aminostats)
amino acids profil in plasma
Time frame: 2 years
Biological measurments
Food preferences
Time frame: 2 years
Device: Treshold taste detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Food Preferences, run by University of Burgundy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Brondel, Professor (03 80 29 34 84, laurent.brondel@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.