Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Nutritional status
研究概览
简要总结
Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients.
The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Diagnose of primary biliary cirrhosis:
- •Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
- •Presence of antimitochondrial antibodies (AMA)
- •Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.
- •Ambulatory patients
- •Diagnose of primary biliary cirrhosis:
- •Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
- •Presence of antimitochondrial antibodies (AMA)
- •Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.
- •Diagnose of liver cirrhosis by two or more of the following criteria:
- •Albumin < 3.4 g/dL
- •INR ≥ 1.3
- •Total bilirubin ≥ 2 mg/dL
- •Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
- •Liver biopsy Ambulatory patients
排除标准
- •Overlapping syndrome with predominant autoimmune hepatitis
- •Hospitalized patients
- •Acute or chronic renal failure
- •Hepatocellular carcinoma
- •Pregnancy
- •Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder)
结局指标
主要结局
Nutritional status
时间窗: Participants will be followed for 6 months
Measured with the following parameters: body weight and height (to calculate BMI), triceps skinfold thickness and mid-arm circumference (to calculate mid-arm muscle circumference. Fat mass, fat free mass, total, intracellular and extracellular body water obtained by bioelectrical impedance analysis, and individual vectors obtained by bioelectrical impedance vector analysis.
次要结局
- Quality of life(Participants will be followed for 6 months)
- Minimal hepatic encephalopathy(Participants will be followed for 6 months)
研究者
ALDO TORRE DELGADILLO
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran