High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis - Full Text View

Purpose

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	Intervention
Primary Biliary Cirrhosis	Dietary Supplement: High protein high fiber diet


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis Dietary Fiber

Genetic and Rare Diseases Information Center resources: Primary Biliary Cholangitis

U.S. FDA Resources

Further study details as provided by ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:

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:

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


Enrollment:	36
Study Start Date:	September 2011
Study Completion Date:	June 2016
Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603199

Locations


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


Study Chair:	Aldo Torre Delgadillo, M.D. M.Sc	INCMNSZ

More Information


Responsible Party:	ALDO TORRE DELGADILLO, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:	NCT01603199 History of Changes
Other Study ID Numbers:	GAS-460-11/12-1
Study First Received:	May 17, 2012
Last Updated:	June 7, 2016

Additional relevant MeSH terms:


Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Pathologic Processes Liver Diseases	Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases

ClinicalTrials.gov processed this record on August 18, 2017