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

Study Overview
=================
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.

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

Conditions
-----------------
Primary Biliary Cirrhosis

Intervention / Treatment
-----------------
* Dietary Supplement: High protein high fiber diet


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary biliary cirrhosis (Non-cirrhotic)<br> | Dietary Supplement: High protein high fiber diet<br>* 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.<br>|
| Experimental: Primary biliary cirrhosis (Cirrhotic)<br> | Dietary Supplement: High protein high fiber diet<br>* 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.<br>|

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 |