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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Current Primary Outcome: 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.


Original Primary Outcome: 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 circunference (to calculated mid-arm muscle circunference, fat mass, fat free mass total, intracellular and extracellular body water obtained by bioelctrical impedance analysis and individual vectors obtained by bioelctrical impedance vector analysis.


Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome:

  • Minimal hepatic encephalopathy [ Time Frame: Participants will be assessed for six months ]
    Assessed by Psycometric 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 ]
    Assessed by CLDQ and SF-36 questionnaries, at visit 0 months and 6 months visit.


Information By: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Dates:
Date Received: July 12, 2012
Date Started: January 2012
Date Completion:
Last Updated: August 18, 2014
Last Verified: August 2014