LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Improved functional capacity (Liver Frailty Index)
研究概览
简要总结
The goal of this clinical trial is to compare food for special medical purposes (Aminolife Plus, by Piemme Pharmatech) vs. placebo in improving muscle mass and function in a cohort of cirrhotic patients.
The main questions it aims to answer are:
- whether functional ability improves in cirrhotic-sarcopenic patients two months after taking the supplement compared with those not taking the supplement.
- whether weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle as per bioimpedance analysis (BIA) in cirrhotic-sarcopenic patients increase two months after taking the supplement compared with those not taking the supplement.
- to assess quality-of-life indices in the two groups.
- to assess differences in groups in terms of plasma metabolite production in the two groups
This is a spontaneous, no PROFIT, pilot interventional study in the form of a randomized clinical trial (RCT), double-blind.
All patients will undergo simple sarcopenia risk identification questions (SARC-F test). All patients recognized to be at risk will be randomized to receive.
- nutritional counseling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counseling according to guidelines + placebo 20 g/day (4 scoops)
for a total of 60 days (2 months). The manufacturing company will provide the product and placebo free of charge. Patients will undergo, at the first visit and at the follow-up visit anthropometric measurements and body composition assessment (by bioimpedance analysis).
In addition, 1 blood sample for metabolomic analysis will be taken at the same visits.
The study will last 12 months.
详细描述
patients will be randomly allocated within the two groups:
- nutritional counselling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counselling according to guidelines + placebo 20 g/day (4 scoops)
The patients will be randomly allocated into two groups: the control group who will not take the treatment and the experimental group who will take the supplement. In detail, patients in the experimental group, in association with nutritional counselling, will take Aminolife plus 20 g/day (4 scoops) for two months (T0-T2).
Patients in the control group, in combination with nutritional counselling, will take placebo 20 g/day (4 scoops) for two months (T0-T2).
The division into the 2 groups will follow a block randomisation algorithm according to the Random Sorting procedure. The allocation sequence will be generated by means of the PASS2022 software.17 The allocation operator will be 'blinded' to the allocation group, just as the operator applying the treatment will not be involved in the evaluation of patients and results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients affected by Liver cirrhosis
- •at any stage of Child (A-B-C) with or without hepatocarcinoma
- •SARC-F suggestive of risk of sarcopenia
- •Age > 18 years
- •Ability to perform Liver Frailty Index test
- •Informed consent to participate in the study.
排除标准
- •SARC-F not suggestive of sarcopenia
- •inability to perform Liver Frailty Index test
- •absence of informed consent
结局指标
主要结局
Improved functional capacity (Liver Frailty Index)
时间窗: 12 months
Improved functional capacity in cirrhotic-sarcopenic patients, assessed by using the Liver Frailty Index test, which has already been validated in the literature and includes 3 continuous parameters (Handgrip strenght test, Chair Stand Test and Balance test).
次要结局
- Improved anthropometric and bioelectrical values and comparing the two(12 months)
- Improved QoL(12 months)
- Differences in terms of plasmatic metabolites(12 months)
研究者
Rinninella Emanuele, MD, PhD
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS