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

Not Applicable

Completed

• Conditions: Primary Biliary Cirrhosis
• Interventions: Dietary Supplement: High protein high fiber diet

• Registration Number: NCT01603199
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Primary Completion: 2015-07
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary biliary cirrhosis (Non-cirrhotic)	High protein high fiber diet	-
Primary biliary cirrhosis (Cirrhotic)	High protein high fiber diet	-

Primary Outcome Measures

Name	Time	Method
Nutritional status	Participants will be followed for 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Participants will be followed for 6 months	Assessed by SF-36 and PBC-40 questionnaires
Minimal hepatic encephalopathy	Participants will be followed for 6 months	Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Mexico