High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
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ClinicalTrials.gov Identifier: NCT01603199 |
Recruitment Status :
Completed
First Posted : May 22, 2012
Last Update Posted : June 8, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Biliary Cirrhosis | Dietary Supplement: High protein high fiber diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis |
Study Start Date : | September 2011 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Primary biliary cirrhosis (Non-cirrhotic) |
Dietary Supplement: High 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. |
Experimental: Primary biliary cirrhosis (Cirrhotic) |
Dietary Supplement: High 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. |
- Nutritional status [ Time Frame: 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.
- Minimal hepatic encephalopathy [ Time Frame: Participants will be followed for 6 months ]Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)
- Quality of life [ Time Frame: Participants will be followed for 6 months ]Assessed by SF-36 and PBC-40 questionnaires

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603199
Mexico | |
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | |
Mexico City, Mexico, 14000 |
Study Chair: | Aldo Torre Delgadillo, M.D. M.Sc | INCMNSZ |
Responsible Party: | ALDO TORRE DELGADILLO, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
ClinicalTrials.gov Identifier: | NCT01603199 |
Other Study ID Numbers: |
GAS-460-11/12-1 |
First Posted: | May 22, 2012 Key Record Dates |
Last Update Posted: | June 8, 2016 |
Last Verified: | June 2016 |
Liver Cirrhosis Liver Cirrhosis, Biliary Fibrosis Pathologic Processes Liver Diseases |
Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases |