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NCT Number: NCT01655121

Effect of High-protein High-fiber Diet 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.

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Cirrhosis Digestive System Diseases Fibrosis Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, D.f., 14000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High protein high fiber diet

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.

Primary outcomes

  1. Nutritional Status

    Time frame: Participants will be assessed for six months

    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 outcomes

  1. Minimal hepatic encephalopathy

    Time frame: Participants will be assessed for six months

    Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.

  2. Quality of life

    Time frame: Participants will be assessed for six months

    Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2012
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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