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

This study is currently recruiting participants.
Verified July 2012 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01655121
First received: July 12, 2012
Last updated: December 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Autoimmune Hepatitis
Cirrhosis
 Dietary Supplement: High protein high fiber diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Nutritional Status [ Time Frame: Participants will be assessed for six months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Participants will be assessed for six months ] [ Designated as safety issue: No ]
    Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.

  • Quality of life [ Time Frame: Participants will be assessed for six months ] [ Designated as safety issue: No ]
    Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655121

Contacts
Contact: Aldo Torre Delgadillo, M.D. 54870900 ext 2711 detoal@yahoo.com

Locations
Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, D.f., Mexico, 14000
Contact: Aldo Torre Delgadillo, M.D. M.Sci     54870900 ext 2711     detoal@yahoo.com    
Contact: Ariadna Karen Flores Balbuena, LN     54870900 ext 2711     nut.ariadnakaren@hotmail.com    
Principal Investigator: Aldo Torre Delgadillo, M.D. M.Sci            
Sub-Investigator: Ariadna Karen Flores Balbuena            
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Aldo Torre Delgadillo, M.D. M.Sc INCMNSZ
  More Information

No publications provided

Responsible Party: ALDO TORRE DELGADILLO, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01655121     History of Changes
Other Study ID Numbers: GAS-501-11/12-1
Study First Received: July 12, 2012
Last Updated: December 5, 2012
Health Authority: Mexico: Secretaria de Salud

Additional relevant MeSH terms:
Hepatitis, Autoimmune
Autoimmune Diseases
Hepatitis
Hepatitis A
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepatitis, Chronic
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013