Trial record 15 of 45 for:    "Primary biliary cirrhosis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
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: August 18, 2014
Last verified: August 2014
  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:


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 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: August 18, 2014
Health Authority: Mexico: Secretaria de Salud

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis
Cholestasis, Intrahepatic
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 22, 2014