Eating BehaviourGREFFENCT02859506
Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
A study testing Respiratory quotient and Olfactory liking in people with Eating Behaviour and Liver Transplant, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eating Behaviour, Liver Transplant
- What is being tested?
- Respiratory quotient and Olfactory liking
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2015to 13 Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons who have provided written informed consent
- persons aged between 18 and 70 years
- persons waiting for a liver transplantation (group LT)
- persons with stable liver damage
- persons waiting for a kidney transplantation (KT)
- healthy subjects (control group) no known disease
Who cannot join
- persons without national health insurance cover
- persons with chronic infection,
- persons with acute infection,
- persons with progressive cancer,
- persons with an antibiotic treatment,
- persons who drink alcohol,
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- pregnant or breast-feeding women,
- persons with an aversion to the foods proposed in the study,
- persons taking treatments known to interfere with gustatory and olfactory performance,
- adults under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.
The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.
- Conditions
- Eating Behaviour, Liver Transplant
- Being tested
- Respiratory quotient, Olfactory liking
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory quotientOther
Olfactory likingOther
| Study group | Role | What they receive |
|---|---|---|
| liver transplant | Experimental | Not described Receives: Other: Respiratory quotient; Other: Olfactory liking |
| kidney transplant | Active comparator | Not described Receives: Other: Respiratory quotient; Other: Olfactory liking |
| control | Placebo comparator | Not described Receives: Other: Respiratory quotient; Other: Olfactory liking |
| stable liver damage | Active comparator | Not described Receives: Other: Respiratory quotient; Other: Olfactory liking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
Measured: At month 0, month 3, month 9 and month 15
Change in olfactory liking compared with baseline values by questionnaire
Measured: At month 0, month 3, month 9 and month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start3 Jul 2015
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviourStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859506
- Sponsor's protocol ID
- BRONDEL INRA 2013
- Acronym
- GREFFE
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2016
- Last updated
- 22 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02859506
- Acronym / sponsor ID
- GREFFE / BRONDEL INRA 2013
- Conditions
- Eating Behaviour, Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Jul 2015 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 9 Aug 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.
Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.
The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| liver transplant | Experimental | Other: Respiratory quotient, Other: Olfactory liking |
| kidney transplant | Active comparator | Other: Respiratory quotient, Other: Olfactory liking |
| control | Placebo comparator | Other: Respiratory quotient, Other: Olfactory liking |
| stable liver damage | Active comparator | Other: Respiratory quotient, Other: Olfactory liking |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- persons who have provided written informed consent
- persons aged between 18 and 70 years
- persons waiting for a liver transplantation (group LT)
- persons with stable liver damage
- persons waiting for a kidney transplantation (KT)
Key exclusion criteria (10 listed)
- persons without national health insurance cover
- persons with chronic infection,
- persons with acute infection,
- persons with progressive cancer,
- persons with an antibiotic treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory quotient | Other | control, kidney transplant, liver transplant, stable liver damage |
| Olfactory liking | Other | control, kidney transplant, liver transplant, stable liver damage |
Primary outcome
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values
Time frame: At month 0, month 3, month 9 and month 15
Change in olfactory liking compared with baseline values by questionnaire
Time frame: At month 0, month 3, month 9 and month 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory quotient and Olfactory liking in people with Eating Behaviour and Liver Transplant, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 22 Feb 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in respiratory quotient (RQ) by indirect calorimetry compared with baseline values (time frame: At month 0, month 3, month 9 and month 15). The study lists 2 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 22 Feb 2024.