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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01603199
Recruitment Status : Completed
First Posted : May 22, 2012
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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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.


Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Dietary Supplement: High protein high fiber diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
Study Start Date : September 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Nutritional status [ Time Frame: 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 :
  1. Minimal hepatic encephalopathy [ Time Frame: Participants will be followed for 6 months ]
    Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)

  2. Quality of life [ Time Frame: Participants will be followed for 6 months ]
    Assessed by SF-36 and PBC-40 questionnaires


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603199


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Study Chair: Aldo Torre Delgadillo, M.D. M.Sc INCMNSZ
More Information
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Responsible Party: ALDO TORRE DELGADILLO, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01603199    
Other Study ID Numbers: GAS-460-11/12-1
First Posted: May 22, 2012    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Cirrhosis, Biliary
Fibrosis
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases