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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Dietary supplement: High protein high fiber diet

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14000
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary biliary cirrhosis (Non-cirrhotic)	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.
Experimental: Primary biliary cirrhosis (Cirrhotic)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Study Chair: Aldo Torre Delgadillo, M.D. M.Sc, INCMNSZ

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 22, 2012

Study Record Updates

• Last Update Posted (Estimate): June 8, 2016
• Last Update Submitted That Met QC Criteria: June 7, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Fibrosis; Liver Cirrhosis; Liver Cirrhosis, Biliary
• Other Study ID Numbers: GAS-460-11/12-1