Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis

Cirrhosis Clinical Trial

Official title: Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Cirrhosis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

• NCT number: NCT01655121
• Study type: Interventional
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Completion date: July 2014