Primary Biliary CirrhosisNCT01603199
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
A study testing High protein high fiber diet in people with Primary Biliary Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Biliary Cirrhosis
- What is being tested?
- High protein high fiber diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14000
About this study
Official title: Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
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.
- Conditions
- Primary Biliary Cirrhosis
- Being tested
- High protein high fiber diet
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein high fiber dietDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary biliary cirrhosis (Non-cirrhotic) | Experimental | Not described Receives: Dietary Supplement: High protein high fiber diet |
| Primary biliary cirrhosis (Cirrhotic) | Experimental | Not described Receives: Dietary Supplement: High protein high fiber diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
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.
Measured: Participants will be followed for 6 months
Secondary outcomes (2)
Minimal hepatic encephalopathy
Assessed by Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF)
Measured: Participants will be followed for 6 months
Quality of life
Assessed by SF-36 and PBC-40 questionnaires
Measured: Participants will be followed for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre Delgadillo, M.D. M.Sc, Study chair, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603199
- Sponsor's protocol ID
- GAS-460-11/12-1
- Status last verified
- Jun 2016
- First submitted
- 17 May 2012
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis
- ClinicalTrials.gov ID
- NCT01603199
- Acronym / sponsor ID
- GAS-460-11/12-1
- Conditions
- Primary Biliary Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary biliary cirrhosis (Non-cirrhotic) | Experimental | Dietary Supplement: High protein high fiber diet |
| Primary biliary cirrhosis (Cirrhotic) | Experimental | Dietary Supplement: High protein high fiber diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Controls
- 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
Key exclusion criteria (6 listed)
- Overlapping syndrome with predominant autoimmune hepatitis
- Hospitalized patients
- Acute or chronic renal failure
- Hepatocellular carcinoma
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein high fiber dietA 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. | Dietary supplement | Primary biliary cirrhosis (Cirrhotic), Primary biliary cirrhosis (Non-cirrhotic) |
Primary outcome
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.
2 secondary outcomes
Minimal hepatic encephalopathy
Time frame: Participants will be followed for 6 months
Quality of life
Time frame: Participants will be followed for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aldo Torre Delgadillo, M.D. M.Sc study chair
INCMNSZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein high fiber diet in people with Primary Biliary Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: Participants will be followed for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.