Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Nutritional Status
研究概览
简要总结
Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure.
There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, 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 (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients.
The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.
详细描述
Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. The monitoring of adherence to the diet will be once a month for the duration of the study period.
There will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. Body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content.
The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied three times during the study and the quality of life questionnaire SF-36 CLDQ and will be held in direct interview at the first visit and at study end.
Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin, angiotensin and aldosterone.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Autoimmune hepatitis (Non cirrhotic)
- •Diagnose of Autoimmune hepatitis
- •Presence of antinuclear antibody (ANA, SMA)
- •Biochemical evidence, based on elevation of transaminases
- •Biopsy compatible with Autoimmune hepatitis
- •Ambulatory patients
- •Autoimmune hepatitis (Cirrhotic)
- •Presence of antinuclear antibody (ANA, SMA)
- •Biochemical evidence, based on elevation of transaminases
- •Biopsy compatible with autoimmune cirrhosis
- •Hepatic cirrhosis by USD
- •Ambulatory patients
- •Diagnose of Autoimmune cirrhosis by two or more of the following criteria:
- •Albumin <3.4g/dl
- •Total bilirubin >2mg/dl
- •Presence of esophageal varices by endoscopy
排除标准
- •Hospitalized patients
- •Overlapping syndrome with predominant primary biliary cirrhosis
- •Chronic renal failure
- •Hepatocellular carcinoma
- •Neuropsychiatric disorders
结局指标
主要结局
Nutritional Status
时间窗: Participants will be assessed for six months
Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated 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 assessed for six months)
- Minimal hepatic encephalopathy(Participants will be assessed for six months)
研究者
ALDO TORRE DELGADILLO
Principal Investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran