Nutritional Assessment in Individuals with Liver Cirrhosis

Not yet recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT06588712
• Lead Sponsor: Université Sorbonne Paris Nord

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Study Start: 2024-10
• Primary Completion: 2026-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nutritional intakes	At enrollment	Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire
Food group intakes	At enrollment	Usual intake of the main food groups, assessed with a validated food frequency questionnaire
Mediterranean diet score	At enrollment	Mediterranean diet score, assessed with a validated food frequency questionnaire
Alcohol intake	At enrollment	Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire
Smoking status	At enrollment	Smoking status, number of pack-years, assessed by questionnaire
Physical activity	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	At enrollment	Sitting time, assessed with the IPAQ short-form
Weight	At enrollment	Self-reported body weight
Height	At enrollment	Self-reported height
Body mass index	At enrollment	Calculated as weight/(height\*height)
Nutritional score	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

Secondary Outcome Measures

Name	Time	Method
Socioeconomic factors	At enrollment	Educational, level, occupation, income
Demographic factors	At enrollment	Gender, marital status, household composition, number of children
Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)	From enrollment to the end of follow-up at 3 years	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)
Follow-up of cirrhotic disease (other hepatic complications)	From enrollment to the end of follow-up at 3 years	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)
Follow-up of cirrhotic disease (extra-hepatic complications)	From enrollment to the end of follow-up at 3 years	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)