Nutritional Assessment in Individuals with Liver Cirrhosis
ConditionLiver Cirrhosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversité Sorbonne Paris Nord
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Child-Pugh C score
Active hepatitis B or C
Patient under legal protection
Patient deprived of liberty
Trial population
Patients with liver cirrhosis
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Patients with liver cirrhosis
Trial outcomes
Primary outcomes
1
Nutritional intakes
Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire
Time frame
At enrollment2
Food group intakes
Usual intake of the main food groups, assessed with a validated food frequency questionnaire
Time frame
At enrollment3
Mediterranean diet score
Mediterranean diet score, assessed with a validated food frequency questionnaire
Time frame
At enrollment4
Alcohol intake
Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire
Time frame
At enrollmentSecondary outcomes
1
Socioeconomic factors
Educational, level, occupation, income
Time frame
At enrollment2
Demographic factors
Gender, marital status, household composition, number of children
Time frame
At enrollment3
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)
Time frame
From enrollment to the end of follow-up at 3 years4
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)
Time frame
From enrollment to the end of follow-up at 3 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Université Sorbonne Paris Nord
Lead sponsor
Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique
Collaborator
Hôpital Avicenne, AP-HP, Service Hépatologie
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: