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NCT Number: NCT06588712

Nutritional Assessment in Individuals with Liver Cirrhosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nutritional intakes

    Time frame: At enrollment

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

  2. Food group intakes

    Time frame: At enrollment

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

  3. Mediterranean diet score

    Time frame: At enrollment

    Mediterranean diet score, assessed with a validated food frequency questionnaire

  4. Alcohol intake

    Time frame: At enrollment

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

  5. Smoking status

    Time frame: At enrollment

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

  6. Physical activity

    Time frame: 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

  7. Sedentary behavior

    Time frame: At enrollment

    Sitting time, assessed with the IPAQ short-form

  8. Weight

    Time frame: At enrollment

    Self-reported body weight

  9. Height

    Time frame: At enrollment

    Self-reported height

  10. Body mass index

    Time frame: At enrollment

    Calculated as weight/(height*height)

  11. Nutritional score

    Time frame: 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 outcomes

  1. Socioeconomic factors

    Time frame: At enrollment

    Educational, level, occupation, income

  2. Demographic factors

    Time frame: At enrollment

    Gender, marital status, household composition, number of children

  3. Follow-up of cirrhotic disease (occurrence of hepatocellular carcinoma)

    Time frame: 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)

  4. Follow-up of cirrhotic disease (other hepatic complications)

    Time frame: 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)

  5. Follow-up of cirrhotic disease (extra-hepatic complications)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Bellicha, PhD

CONTACT

[email protected]

00(33)148388933

Laure Legris

CONTACT

[email protected]

00(33)148388933

Sponsors and collaborators

Lead sponsor

Université Sorbonne Paris Nord

Other

Collaborators

  • Hôpital Avicenne, AP-HP, Service Hépatologie
  • Hôpital Henri Mondor, AP-HP, Unité de Recherche Clinique

Registry information

Official study title

Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)

Acronym: Nutri-CIRR

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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