Nutritional Assessment in Individuals with Liver Cirrhosis

NCT06588712 | Not Yet Recruiting DMC

• 1 other identifier: 2023-A01392-43
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (11)

• Nutritional intakes

  Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire

  At enrollment

• Food group intakes

  Usual intake of the main food groups, assessed with a validated food frequency questionnaire

  At enrollment

• Mediterranean diet score

  Mediterranean diet score, assessed with a validated food frequency questionnaire

  At enrollment

• Alcohol intake

  Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire

  At enrollment

• Smoking status

  Smoking status, number of pack-years, assessed by questionnaire

  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

  At enrollment

• Sedentary behavior

  Sitting time, assessed with the IPAQ short-form

  At enrollment

• Weight

  Self-reported body weight

  At enrollment

• Height

  Self-reported height

  At enrollment

• Body mass index

  Calculated as weight/(height\*height)

  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

  At enrollment

Secondary Outcomes (5)

• Socioeconomic factors

  At enrollment

• Demographic factors

  At enrollment

• Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)

  From enrollment to the end of follow-up at 3 years

• Follow-up of cirrhotic disease (other hepatic complications)

  From enrollment to the end of follow-up at 3 years

• Follow-up of cirrhotic disease (extra-hepatic complications)

  From enrollment to the end of follow-up at 3 years

Study Arms (1)

Patients with liver cirrhosis

Patients with liver cirrhosis are included in the cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Sorbonne Paris Nord: lead
• Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique: collaborator
• Hôpital Avicenne, AP-HP, Service Hépatologie: collaborator

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice Bellicha, PhD

  Université Sorbonne Paris Nord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Bellicha, PhD

CONTACT

00(33)148388933; a.bellicha@eren.smbh.univ-paris13.fr

Laure Legris

CONTACT

00(33)148388933; laure.legris@eren.smbh.univ-paris13.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09