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

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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Autoimmune Hepatitis
• Intervention / Treatment: Dietary supplement: High protein high fiber diet

Detailed 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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • D.f.
    • Mexico City, D.f., Mexico, 14000
      • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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
• INR>1.2
• Total bilirubin >2mg/dl
• Presence of esophageal varices by endoscopy

Exclusion Criteria:

• Hospitalized patients
• Overlapping syndrome with predominant primary biliary cirrhosis
• Chronic renal failure
• Hepatocellular carcinoma
• Neuropsychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autoimmune hepatitis (Non-cirrhotic); A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.	Dietary supplement: High protein high fiber diet; A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months. Each participant will receive nutritional counseling once month during six months.
Experimental: Autoimmune hepatitis (Cirrhotic); A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.	Dietary supplement: High protein high fiber diet; A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months. Each participant will receive nutritional counseling once month during six months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status	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.	Participants will be assessed for six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal hepatic encephalopathy	Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.	Participants will be assessed for six months
Quality of life	Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.	Participants will be assessed for six months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 18, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis; Hepatitis A; Hepatitis, Autoimmune
• Other Study ID Numbers: GAS-501-11/12-1