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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Completed

Conditions: Primary Biliary Cirrhosis

Treatments: Dietary Supplement: High protein high fiber diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01603199

GAS-460-11/12-1

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Primary biliary cirrhosis (Non-cirrhotic)

Experimental group

Treatment:

Dietary Supplement: High protein high fiber diet

Primary biliary cirrhosis (Cirrhotic)

Experimental group

Treatment:

Dietary Supplement: High protein high fiber diet