Liver CirrhosisNutri-CIRRNCT06588712
Nutritional Assessment in Individuals with Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Université Sorbonne Paris Nord.
Trial summary
The risk factors for liver cirrhosis are well identified and primarily include excessive and prolonged alcohol consumption, as well as metabolic syndrome or infection with hepatitis B and C viruses. However, the factors that can predict the progression of the disease are still largely unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis
Who may be able to join
- Adult patients
- Histologically proven cirrhosis or unequivocally suggested by non-invasive tests
- No HCC on imaging dated less than 3 months
- Ability to understand and read French, at the investigator\'s discretion
- Affiliation with a social security system
Who cannot join
- Child-Pugh C score
- Active hepatitis B or C
- Patient under legal protection
- Patient deprived of liberty
- Pregnant or breastfeeding woman, as known by the investigator
- Patient under State Medical Assistance (AME)
- Patient opposed to participating in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)
The risk factors for liver cirrhosis are well identified and primarily include excessive and prolonged alcohol consumption, as well as metabolic syndrome or infection with hepatitis B and C viruses. However, the factors that can predict the progression of the disease are still largely unknown. The role of nutritional factors, in particular, has been insufficiently studied in chronic liver diseases such as cirrhosis. Beyond malnutrition and nutritional deficiencies, whose roles have been well studied, it appears that other nutritional factors, such as adherence to dietary recommendations that consider the consumption of various food groups, have been little studied in patients with liver cirrhosis. Studies involving a large number of participants are essential to better describe the typical nutritional profiles of these patients, taking into account their diet, as well as their alcohol consumption and physical activity.
Therefore, the main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors (diet, alcohol consumption and physical activity) and smoking status.
Read the detailed description
The Nutri-CIRR study is an observational study taking place in France and assessing nutritional factors among patients with liver cirrhosis. After inclusion in the study, all patients are invited to complete validated online questionnaires on diet, alcohol consumption, physical activity, as well as socioeconomic and other lifestyle characteristics. Questionnaires are completed at one occasion.
The main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors (diet, alcohol consumption and physical activity) and smoking status.
Secondary aims are:
- Secondary aim #1: To describe values of the PNNS-GS2 score categorized into quantiles, which takes into account nutritional factors (diet, alcohol consumption and physical activity)
- Secondary aim #2: To evaluate the associations between nutritional factors (diet, alcohol consumption, physical activity) and the subsequent occurrence of hepatocellular carcinoma
- Secondary aim #3: To determine whether nutritional factors (diet, alcohol consumption, physical activity) are associated with competing hepatic risks (ascites, jaundice, bleeding due to portal hypertension, severe bacterial infections) and extra-hepatic risks (cardiovascular events, extra-hepatic cancers).
To address secondary aims #2 and #3, data from the Nutri-CIRR study will be matched with data from the FASTRAK study (NCT05095714), which monitors the liver disease progression.
- Conditions
- Liver Cirrhosis
- Medical subject headings
- Liver Cirrhosis
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 |
|---|---|---|
| Patients with liver cirrhosis | Patients with liver cirrhosis are included in the cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional intakes
Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire
Measured: At enrollment
Food group intakes
Usual intake of the main food groups, assessed with a validated food frequency questionnaire
Measured: At enrollment
Mediterranean diet score
Mediterranean diet score, assessed with a validated food frequency questionnaire
Measured: At enrollment
Alcohol intake
Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire
Measured: At enrollment
Smoking status
Smoking status, number of pack-years, assessed by questionnaire
Measured: At enrollment
Physical activity
Duration of moderate and vigorous physical activity, duration of walking, physical activity level (low, moderate, high, calculated using the duration of moderate, vigorous physical activity and walking), assessed with the IPAQ short-form
Measured: At enrollment
Sedentary behavior
Sitting time, assessed with the IPAQ short-form
Measured: At enrollment
Weight
Self-reported body weight
Measured: At enrollment
Height
Self-reported height
Measured: At enrollment
Body mass index
Calculated as weight/(height*height)
Measured: At enrollment
Nutritional score
PNNS-GS2 is a nutritional score calculated using data on dietary intake, alcohol intake and physical activity. A higher score indicates a greater nutritional quality
Measured: At enrollment
Secondary outcomes (5)
Socioeconomic factors
Educational, level, occupation, income
Measured: At enrollment
Demographic factors
Gender, marital status, household composition, number of children
Measured: At enrollment
Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)
Occurrence of hepatocellular carcinoma. These data will be collected as part of a matching process with the FASTRAK study (NCT05095714) for patients included in both studies (Nutri-CIRR + FASTRAK)
Measured: From enrollment to the end of follow-up at 3 years
Follow-up of cirrhotic disease (other hepatic complications)
Occurrence of other hepatic complications (ascites, jaundice, bleeding due to portal hypertension, severe bacterial infections). These data will be collected as part of a matching process with the FASTRAK study (NCT05095714) for patients included in both studies (Nutri-CIRR + FASTRAK)
Measured: From enrollment to the end of follow-up at 3 years
Follow-up of cirrhotic disease (extra-hepatic complications)
Occurrence of extra-hepatic complications (cardiovascular events, extra-hepatic cancers). These data will be collected as part of a matching process with the FASTRAK study (NCT05095714) for patients included in both studies (Nutri-CIRR + FASTRAK)
Measured: From enrollment to the end of follow-up at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Sorbonne Paris Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique, Hôpital Avicenne, AP-HP, Service Hépatologie
- Responsible party
- Sponsor
- Investigators
- Alice Bellicha, PhD, Principal investigator, Université Sorbonne Paris Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588712
- Sponsor's protocol ID
- 2023-A01392-43
- Acronym
- Nutri-CIRR
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data described in the article, code book, and analytic code will be made available upon request. Researchers of a public institution can submit a collaboration request including their institution and a brief description of their project to the principal investigator. All requests will be reviewed by the scientific team of the project. A financial contribution may be requested. If the collaboration is accepted, a data access agreement will be necessary and appropriate authorizations from the competent administrative authorities may be needed. In accordance with existing regulations, no personal data will be accessible.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)
- ClinicalTrials.gov ID
- NCT06588712
- Acronym / sponsor ID
- Nutri-CIRR / 2023-A01392-43
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Université Sorbonne Paris NordUniversity, hospital or other
- Collaborators
- Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique, Hôpital Avicenne, AP-HP, Service Hépatologie
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
The risk factors for liver cirrhosis are well identified and primarily include excessive and prolonged alcohol consumption, as well as metabolic syndrome or infection with hepatitis B and C viruses. However, the factors that can predict the progression of the disease are still largely unknown. The role of nutritional factors, in particular, has been insufficiently studied in chronic liver diseases such as cirrhosis. Beyond malnutrition and nutritional deficiencies, whose roles have been well studied, it appears that other nutritional factors, such as adherence to dietary recommendations that consider the consumption of various food groups, have been little studied in patients with liver cirrhosis. Studies involving a large number of participants are essential to better describe the typical nutritional profiles of these patients, taking into account their diet, as well as their alcohol consumption and physical activity.
Therefore, the main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors (diet, alcohol consumption and physical activity) and smoking status.
Detailed description
The Nutri-CIRR study is an observational study taking place in France and assessing nutritional factors among patients with liver cirrhosis. After inclusion in the study, all patients are invited to complete validated online questionnaires on diet, alcohol consumption, physical activity, as well as socioeconomic and other lifestyle characteristics. Questionnaires are completed at one occasion.
The main aim of the Nutri-CIRR project is to identify and characterize typical profiles of patients with hepatic cirrhosis in terms of nutritional factors (diet, alcohol consumption and physical activity) and smoking status.
Secondary aims are:
- Secondary aim #1: To describe values of the PNNS-GS2 score categorized into quantiles, which takes into account nutritional factors (diet, alcohol consumption and physical activity)
- Secondary aim #2: To evaluate the associations between nutritional factors (diet, alcohol consumption, physical activity) and the subsequent occurrence of hepatocellular carcinoma
- Secondary aim #3: To determine whether nutritional factors (diet, alcohol consumption, physical activity) are associated with competing hepatic risks (ascites, jaundice, bleeding due to portal hypertension, severe bacterial infections) and extra-hepatic risks (cardiovascular events, extra-hepatic cancers).
To address secondary aims #2 and #3, data from the Nutri-CIRR study will be matched with data from the FASTRAK study (NCT05095714), which monitors the liver disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis | – | –Patients with liver cirrhosis are included in the cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis
Key inclusion criteria (5 listed)
- Adult patients
- Histologically proven cirrhosis or unequivocally suggested by non-invasive tests
- No HCC on imaging dated less than 3 months
- Ability to understand and read French, at the investigator\'s discretion
- Affiliation with a social security system
Key exclusion criteria (7 listed)
- Child-Pugh C score
- Active hepatitis B or C
- Patient under legal protection
- Patient deprived of liberty
- Pregnant or breastfeeding woman, as known by the investigator
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
Nutritional intakes
Time frame: At enrollment
Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire
Food group intakes
Time frame: At enrollment
Usual intake of the main food groups, assessed with a validated food frequency questionnaire
Mediterranean diet score
Time frame: At enrollment
Mediterranean diet score, assessed with a validated food frequency questionnaire
Alcohol intake
Time frame: At enrollment
Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire
Smoking status
Time frame: At enrollment
Smoking status, number of pack-years, assessed by questionnaire
Physical activity
Time frame: At enrollment
Duration of moderate and vigorous physical activity, duration of walking, physical activity level (low, moderate, high, calculated using the duration of moderate, vigorous physical activity and walking), assessed with the IPAQ short-form
Sedentary behavior
Time frame: At enrollment
Sitting time, assessed with the IPAQ short-form
Weight
Time frame: At enrollment
Self-reported body weight
Height
Time frame: At enrollment
Self-reported height
Body mass index
Time frame: At enrollment
Calculated as weight/(height*height)
Nutritional score
Time frame: At enrollment
PNNS-GS2 is a nutritional score calculated using data on dietary intake, alcohol intake and physical activity. A higher score indicates a greater nutritional quality
5 secondary outcomes
Socioeconomic factors
Time frame: At enrollment
Demographic factors
Time frame: At enrollment
Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)
Time frame: From enrollment to the end of follow-up at 3 years
Follow-up of cirrhotic disease (other hepatic complications)
Time frame: From enrollment to the end of follow-up at 3 years
Follow-up of cirrhotic disease (extra-hepatic complications)
Time frame: From enrollment to the end of follow-up at 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided. Data described in the article, code book, and analytic code will be made available upon request. Researchers of a public institution can submit a collaboration request including their institution and a brief description of their project to the principal investigator. All requests will be reviewed by the scientific team of the project. A financial contribution may be requested. If the collaboration is accepted, a data access agreement will be necessary and appropriate authorizations from the competent administrative authorities may be needed. In accordance with existing regulations, no personal data will be accessible.
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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.
Alice Bellicha, PhD principal investigator
Université Sorbonne Paris Nord
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Université Sorbonne Paris Nord.
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 5 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Bellicha, PhD (00(33)148388933, a.bellicha@eren.smbh.univ-paris13.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional intakes (time frame: At enrollment). The study lists 11 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 19 Sep 2024.