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

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
High protein high fiber diet
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Biliary Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary biliary cirrhosis (Non-cirrhotic)

Primary biliary cirrhosis (Cirrhotic)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Minimal hepatic encephalopathy
Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)
Quality of life
Assessed by SF-36 and PBC-40 questionnaires

Full Information

First Posted
May 17, 2012
Last Updated
June 7, 2016
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01603199
Brief Title
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
Official Title
Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary biliary cirrhosis (Non-cirrhotic)
Arm Type
Experimental
Arm Title
Primary biliary cirrhosis (Cirrhotic)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein high fiber diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status
Description
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.
Time Frame
Participants will be followed for 6 months
Secondary Outcome Measure Information:
Title
Minimal hepatic encephalopathy
Description
Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)
Time Frame
Participants will be followed for 6 months
Title
Quality of life
Description
Assessed by SF-36 and PBC-40 questionnaires
Time Frame
Participants will be followed for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldo Torre Delgadillo, M.D. M.Sc
Organizational Affiliation
INCMNSZ
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

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

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