Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Reversal of minimal hepatic encephalopathy intervention)
研究概览
简要总结
A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. All patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. The supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.
详细描述
The protein in the diet is a major source of ammonia in blood, which is considered one of the factors involved in the pathogenesis of hepatic encephalopathy. However ; it is also known than the restriction on the consumption of protein predisposes to depletion of muscle mass, and increase the risk to develop overt hepatic encephalopathy, due to the muscle role in the detoxification of ammonia in presence of liver failure. Currently, the type and amount of protein in the diet to treat minimal hepatic encephalopathy (MHE) is unknown. In this study, the investigators will administrated two types of protein content in patients with MHE: a high protein diet (1.5 g/kg/day) vs a normal protein diet (0.8 g/kg/day) during 1 month.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cirrhosis of any etiology
- •Men and women between 18 and 70 years.
- •Right-holders of the Mexican Social Security Institute
- •Patients who agree to participate in the study and signed the informed consent
排除标准
- •Recent history of alcohol abuse and/or drugs (less than 6 weeks).
- •Illiterate
- •Alcoholic cirrhosis
- •History and/or diagnosis of overt hepatic encephalopathy
- •Consumption of psychotropic medications (benzodiazepines, antiepileptics)
- •Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements.
- •History of chronic renal disease or heart failure
- •Patients with gastrointestinal bleeding
- •History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests
- •Diagnosis of bacterial overgrowth
- •Diagnosis of liver cancer
- •Patients with ophthalmologic disorders
结局指标
主要结局
Reversal of minimal hepatic encephalopathy intervention)
时间窗: 1 month
Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention
次要结局
- Nutritional Status(1 month)
- Incidence of hepatic encephalopathy(1 month)
研究者
Segundo Moran Villota
Asociado B
Coordinación de Investigación en Salud, Mexico