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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655121
• Other study ID #: GAS-501-11/12-1
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: August 18, 2014
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 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

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No