Nutritional Assessment in Individuals with Liver Cirrhosis (Nutri-CIRR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Nutritional intakes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Nutritional intakes
时间窗: At enrollment
Usual macronutrient and micronutrient intakes, assessed with a validated food frequency questionnaire
Food group intakes
时间窗: At enrollment
Usual intake of the main food groups, assessed with a validated food frequency questionnaire
Mediterranean diet score
时间窗: At enrollment
Mediterranean diet score, assessed with a validated food frequency questionnaire
Alcohol intake
时间窗: At enrollment
Usual alcohol intake, total and by type of alcoholic beverages, assessed with a validated food frequency questionnaire
Smoking status
时间窗: At enrollment
Smoking status, number of pack-years, assessed by questionnaire
Physical activity
时间窗: 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
时间窗: At enrollment
Sitting time, assessed with the IPAQ short-form
Weight
时间窗: At enrollment
Self-reported body weight
Height
时间窗: At enrollment
Self-reported height
Body mass index
时间窗: At enrollment
Calculated as weight/(height\*height)
Nutritional score
时间窗: 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
次要结局
- 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)