High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
This study is currently recruiting participants.
Verified November 2012 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01603199
First received: May 17, 2012
Last updated: November 30, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Primary Biliary Cirrhosis |
Dietary Supplement: High protein high fiber diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
progressive familial intrahepatic cholestasis
U.S. FDA Resources
Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Primary Outcome Measures:
- Nutritional status [ Time Frame: Participants will be followed for 6 months ] [ Designated as safety issue: No ]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 Outcome Measures:
- Minimal hepatic encephalopathy [ Time Frame: Participants will be followed for 6 months ] [ Designated as safety issue: No ]Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)
- Quality of life [ Time Frame: Participants will be followed for 6 months ] [ Designated as safety issue: No ]Assessed by SF-36 and PBC-40 questionnaires
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603199
Contacts
| Contact: Aldo Torre Delgadillo, M.D. | 54870900 ext 2711 | detoal@yahoo.com |
Locations
| Mexico | |
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Recruiting |
| Mexico City, Mexico, 14000 | |
| Contact: Aldo Torre Delgadillo, M.D. M.Sci 54870900 ext 2711 detoal@yahoo.com | |
| Contact: Astrid Ruiz Margáin 54870900 ext 2711 astridrm13@gmail.com | |
| Principal Investigator: Aldo Torre Delgadillo, M.D. M.Sci | |
| Sub-Investigator: Pilar Milke García, Ph. D. | |
| Sub-Investigator: Astrid Ruiz Margáin | |
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
| Study Chair: | Aldo Torre Delgadillo, M.D. M.Sc | INCMNSZ |
More Information
No publications provided
| Responsible Party: | ALDO TORRE DELGADILLO, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| ClinicalTrials.gov Identifier: | NCT01603199 History of Changes |
| Other Study ID Numbers: | GAS-460-11/12-1 |
| Study First Received: | May 17, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | Mexico: Secretaria de Salud |
Additional relevant MeSH terms:
|
Liver Cirrhosis, Biliary Liver Cirrhosis Fibrosis Cholestasis, Intrahepatic Cholestasis |
Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Liver Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013