High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis

Primary Biliary Cirrhosis Clinical Trial

Official title:

Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603199
• Other study ID #: GAS-460-11/12-1
• Status: Completed
• Phase: N/A
• First received: May 17, 2012
• Last updated: June 7, 2016
• Start date: September 2011
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• 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

Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, 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- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients.

The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Controls

Diagnose of primary biliary cirrhosis:

• Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation

• Presence of antimitochondrial antibodies (AMA)

• Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Ambulatory patients

• Cases

Diagnose of primary biliary cirrhosis:

• Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation

• Presence of antimitochondrial antibodies (AMA)

• Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Diagnose of liver cirrhosis by two or more of the following criteria:

• Albumin < 3.4 g/dL

• INR = 1.3

• Total bilirubin = 2 mg/dL

• Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)

• Liver biopsy Ambulatory patients

Exclusion Criteria:

• Overlapping syndrome with predominant autoimmune hepatitis

• Hospitalized patients

• Acute or chronic renal failure

• Hepatocellular carcinoma

• Pregnancy

• Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

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.

Locations

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

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 thickness and mid-arm circumference (to calculate 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 followed for 6 months	No
Secondary	Minimal hepatic encephalopathy	Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)	Participants will be followed for 6 months	No
Secondary	Quality of life	Assessed by SF-36 and PBC-40 questionnaires	Participants will be followed for 6 months	No