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

NCT ID: NCT01655121

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

Brief 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.

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.

Conditions

Autoimmune Hepatitis; Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High protein high fiber diet

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

High protein high fiber diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

ALDO TORRE DELGADILLO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Torre Delgadillo, M.D. M.Sc

Role: PRINCIPAL_INVESTIGATOR

INCMNSZ

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., Mexico

Countries

Mexico

Other Identifiers

GAS-501-11/12-1

Identifier Type: -

Identifier Source: org_study_id