Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change of muscle mass in patients with sarcopenia
研究概览
简要总结
In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.
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
- Triple (Participant, Care Provider, 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
- •Cirrhotic patients with sarcopenia in abdominal CT.
排除标准
- •chronic renal failure or being on hemodialysis
- •active hepatitis B or C virus infection
- •active alcohol abuse
- •coinfection with human immunodeficiency virus
- •renal or previous liver transplantation
- •history of neoplasia requiring chemotherapy or radiotherapy
- •hepatocellular carcinoma outside of Milan criteria
- •unwillingness to participate in the study.
研究组 & 干预措施
BRCA
They were in treatment with BRCA and standard treatment based on nutritional intervention and physical exercise.
干预措施: Branched chain amino acids (BRCA) (Dietary Supplement)
Placebo
They only were on standard treatment based on nutritional intervention and physical exercise.
干预措施: Branched chain amino acids (BRCA) (Dietary Supplement)
结局指标
主要结局
Change of muscle mass in patients with sarcopenia
时间窗: 12 weeks
To assess whether to add to dietary and physical activity recommendations, nutritional supplements with BRCA under usual clinical conditions can lead to a greater change of muscle mass in patients with sarcopenia
次要结局
未报告次要终点
研究者
Jose Luis Calleja
Director. Clinical Research
Puerta de Hierro University Hospital