Clinical trial NCT01603199: High-protein High-fiber Diet in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Biliary Cirrhosis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2012-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Nutritional status
timeFrame: Participants will be followed for 6 months
Secondary outcomes:
measure: Minimal hepatic encephalopathy
timeFrame: Participants will be followed for 6 months
measure: Quality of life
timeFrame: Participants will be followed for 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: INCMNSZ
name: Aldo Torre Delgadillo, M.D. M.Sc
role: STUDY_CHAIR
References: