Primary Biliary Cirrhosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHigh 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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status | 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
| Measure | Time frame | Description |
|---|---|---|
| Minimal hepatic encephalopathy | Participants will be followed for 6 months | Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) |
| Quality of life | Participants will be followed for 6 months | Assessed by SF-36 and PBC-40 questionnaires |
Countries
Mexico
Outcome results
None listed