Clinical trial NCT06588712: Nutritional Assessment in Individuals with Liver Cirrhosis
Official title: Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Université Sorbonne Paris Nord
Sponsor class: OTHER
Collaborators: name: Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique
name: Hôpital Avicenne, AP-HP, Service Hépatologie
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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\&#39;s discretion
* Affiliation with a social security system

Exclusion Criteria:

* 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

Primary outcomes:
measure: Nutritional intakes
timeFrame: At enrollment
measure: Food group intakes
timeFrame: At enrollment
measure: Mediterranean diet score
timeFrame: At enrollment
measure: Alcohol intake
timeFrame: At enrollment
measure: Smoking status
timeFrame: At enrollment
measure: Physical activity
timeFrame: At enrollment
measure: Sedentary behavior
timeFrame: At enrollment
measure: Weight
timeFrame: At enrollment
measure: Height
timeFrame: At enrollment
measure: Body mass index
timeFrame: At enrollment
measure: Nutritional score
timeFrame: At enrollment
Secondary outcomes:
measure: Socioeconomic factors
timeFrame: At enrollment
measure: Demographic factors
timeFrame: At enrollment
measure: Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)
timeFrame: From enrollment to the end of follow-up at 3 years
measure: Follow-up of cirrhotic disease (other hepatic complications)
timeFrame: From enrollment to the end of follow-up at 3 years
measure: Follow-up of cirrhotic disease (extra-hepatic complications)
timeFrame: From enrollment to the end of follow-up at 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Université Sorbonne Paris Nord
name: Alice Bellicha, PhD
role: PRINCIPAL_INVESTIGATOR
References: