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

Primary Purpose

Autoimmune Hepatitis, Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
High protein high fiber diet
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autoimmune Hepatitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Autoimmune hepatitis (Non-cirrhotic)

Autoimmune hepatitis (Cirrhotic)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Minimal hepatic encephalopathy
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.
Quality of life
Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.

Full Information

First Posted
July 12, 2012
Last Updated
August 18, 2014
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01655121
Brief Title
Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis
Official Title
Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis, Cirrhosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autoimmune hepatitis (Non-cirrhotic)
Arm Type
Experimental
Arm Description
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.
Arm Title
Autoimmune hepatitis (Cirrhotic)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein high fiber diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional Status
Description
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.
Time Frame
Participants will be assessed for six months
Secondary Outcome Measure Information:
Title
Minimal hepatic encephalopathy
Description
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.
Time Frame
Participants will be assessed for six months
Title
Quality of life
Description
Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.
Time Frame
Participants will be assessed for six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre Delgadillo, M.D. M.Sc
Organizational Affiliation
INCMNSZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

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

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