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

NCT01603199 | Completed

• 1 other identifier: GAS-460-11/12-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Biliary Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Minimal hepatic encephalopathy

  Participants will be followed for 6 months

• Quality of life

  Participants will be followed for 6 months

Study Arms (2)

Primary biliary cirrhosis (Non-cirrhotic)

EXPERIMENTAL

Dietary Supplement: High protein high fiber diet

Primary biliary cirrhosis (Cirrhotic)

EXPERIMENTAL

Dietary Supplement: High protein high fiber diet

Interventions

High protein high fiber diet DIETARY_SUPPLEMENT

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 biliary cirrhosis (Cirrhotic); Primary biliary cirrhosis (Non-cirrhotic)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aldo Torre Delgadillo, M.D. M.Sc

  INCMNSZ

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 22, 2012
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

ME (1)