Nutritional Assessment in Individuals with Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)
Overview
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.
Primary outcome measures
- Nutritional intakes [Time frame: At enrollment]
- Food group intakes [Time frame: At enrollment]
- Mediterranean diet score [Time frame: At enrollment]
- Alcohol intake [Time frame: At enrollment]
- Smoking status [Time frame: At enrollment]
- Physical activity [Time frame: At enrollment]
- Sedentary behavior [Time frame: At enrollment]
- Weight [Time frame: At enrollment]
- Height [Time frame: At enrollment]
- Body mass index [Time frame: At enrollment]
Secondary outcome measures (5)
- 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]
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\'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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06588712 · 2023-A01392-43