The Effect of Calcium β-hydroxy-β-methylbutyrate Supplementation in Sarcopenia in Liver Cirrhosis：A Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in skeletal muscle mass
研究概览
简要总结
This study is to evaluate the effect of CaHMB in the treatment of sarcopenia in liver cirrhosis.
详细描述
The study is a randomized double-blind controlled trial. Patients randomly enter into two treatment groups: 1) the CaHMB group and 2) the placebo group. Treatment allocation is by block randomization, with an one-to-one ratio for CaHMB and placebo. The results are concealed in opaque envelopes. Patients will report their daily diets with an online software. Patients will come for clinic after 4 weeks and 12 weeks, receiving laboratory tests and sarcopenia evaluation, and events of primary and secondary outcomes will be analyzed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed of cirrhosis with imaging or liver biopsy;
- •diagnosis of portal hypertension with endoscopy or radiography；
- •assessed total muscle mass at the level of L3 (<42 cm2/m2 for male and <38 cm2/m2 for female)
- •has signed an informed consent form.
排除标准
- •diagnosed as hepatic cell cancer;
- •complicated with malignancy, renal failure, diabetes mellitus;
- •comorbidities including heart failure or pulmonary disease;
- •current use of drugs that affect skeletal muscle metabolism;
- •be allergic to the experimental food;
- •participated other clinical trials in the past 3 months;
- •other conditions that researchers consider not suitable for this study
研究组 & 干预措施
CaHMB
CaHMB Group (n=60) will receive CaHMB twice a day and a late evening snack every night for 12 weeks. A specialized, ready-to-drink liquid with 34 kcal, 8.5 g carbohydrate, 1.5g calcium-HMB. The late evening snack is a drink with low-Glycemic Index carbohydrate with 112 kcal.
干预措施: CaHMB (Dietary Supplement)
Control
Control Group (n=60) will receive placebo twice a day and placebo every night for 12 weeks with similar composition but without HMB. The late evening snack is a drink with low-Glycemic Index carbohydrate with 112 kcal.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Changes in skeletal muscle mass
时间窗: Baseline and 12 weeks
Changes of total muscle mass at the level of L3 in CT, analysed by the total cross-sectional area of muscle in centimetres squared (cm2)
次要结局
- Protein metabolic markers(Baseline and 12 weeks)
- Changes in intramuscular fat deposition(Baseline and 12 weeks)
- Changes in total body weight(Baseline and 12 weeks)
- Grip strength(Baseline and 12 weeks)