Autoimmune HepatitisNCT01655121
Effect of High-protein High-fiber Diet in Patients With Autoimmune Hepatitis
A study testing High protein high fiber diet in people with Autoimmune Hepatitis and Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hepatitis, Cirrhosis
- What is being tested?
- High protein high fiber diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2012to Jul 2014
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Autoimmune hepatitis (Non cirrhotic)
- Diagnose of Autoimmune hepatitis
- Presence of antinuclear antibody (ANA, SMA)
- Biochemical evidence, based on elevation of transaminases
- Biopsy compatible with Autoimmune hepatitis
- Ambulatory patients
Show all 17Show fewer
- Autoimmune hepatitis (Cirrhotic)
- Presence of antinuclear antibody (ANA, SMA)
- Biochemical evidence, based on elevation of transaminases
- Biopsy compatible with autoimmune cirrhosis
- Hepatic cirrhosis by USD
- Ambulatory patients
- Diagnose of Autoimmune cirrhosis by two or more of the following criteria:
- Albumin <3.4g/dl
- INR>1.2
- Total bilirubin >2mg/dl
- Presence of esophageal varices by endoscopy
Who cannot join
- Hospitalized patients
- Overlapping syndrome with predominant primary biliary cirrhosis
- Chronic renal failure
- Hepatocellular carcinoma
- Neuropsychiatric disorders
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, D.f., 14000
About this study
Official title: Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis
Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure.
There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, 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 (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients.
The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.
Read the detailed description
Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. The monitoring of adherence to the diet will be once a month for the duration of the study period.
There will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. Body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content.
The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied three times during the study and the quality of life questionnaire SF-36 CLDQ and will be held in direct interview at the first visit and at study end.
Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin, angiotensin and aldosterone.
- Conditions
- Autoimmune Hepatitis, Cirrhosis
- Being tested
- High protein high fiber diet
- Medical subject headings
- Hepatitis, Autoimmune, Fibrosis
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.
Each participant will receive nutritional counseling once month during six months.
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune hepatitis (Non-cirrhotic) | Experimental | 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. Receives: Dietary Supplement: High protein high fiber diet |
| Autoimmune hepatitis (Cirrhotic) | Experimental | 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. 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 and mid-arm circumference (to calculated 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 assessed for six months
Secondary outcomes (2)
Minimal hepatic encephalopathy
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF), at visit 0 months and 6 months visit.
Measured: Participants will be assessed for six months
Quality of life
Assessed by CLDQ and SF-36 questionnaires, at visit 0 months and 6 months visit.
Measured: Participants will be assessed for six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies 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
- 40 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, Principal investigator, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655121
- Sponsor's protocol ID
- GAS-501-11/12-1
- Status last verified
- Aug 2014
- First submitted
- 12 Jul 2012
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High-protein High-fiber Diet and Nutritional Status, Serum Ammonia Concentration and Plasma Cytokines in Patients With Autoimmune Hepatitis
- ClinicalTrials.gov ID
- NCT01655121
- Acronym / sponsor ID
- GAS-501-11/12-1
- Conditions
- Autoimmune Hepatitis, Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Aug 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.
Autoimmune hepatitis is a chronic disease of the liver caused by an alteration of the immune response that attacks the body's own hepatocytes, progressively, leading to cirrhosis and liver failure.
There are few studies on dietary management in hepatitis and most of theme have focused on micronutrients specifically vitamin D to prevent osteoporosis, and decreased symptoms of other diseases associated, 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 (1.2g/kg) has shown to decrease endogenous catabolism in cirrhotics patients.
The implementation of a high protein high fiber nutrition plan and improves nutritional status of patients with autoimmune cirrhosis.
Detailed description
Each participant will receive a high protein (1.2g/kg/day) and high fiber (30g/day) dietary plan. The monitoring of adherence to the diet will be once a month for the duration of the study period.
There will be an nutritional assessment by anthropometric techniques: arm circumference, triceps skinfold, weight, height and body mass index as parameters of malnutrition by taking the standard for cirrhotic patients. Body composition was measured by bioelectric impedance to obtain fat mass, lean and total fluid content.
The presence of minimal hepatic encephalopathy will be assessed by PHES and CFF and applied three times during the study and the quality of life questionnaire SF-36 CLDQ and will be held in direct interview at the first visit and at study end.
Were also measured serum concentrations of ammonium, TNF-alpha, IL-1, IL-6, IL-10, renin, angiotensin and aldosterone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoimmune hepatitis (Non-cirrhotic) | Experimental | Dietary Supplement: 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. |
| Autoimmune hepatitis (Cirrhotic) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Autoimmune hepatitis (Non cirrhotic)
- Diagnose of Autoimmune hepatitis
- Presence of antinuclear antibody (ANA, SMA)
- Biochemical evidence, based on elevation of transaminases
- Biopsy compatible with Autoimmune hepatitis
Key exclusion criteria (5 listed)
- Hospitalized patients
- Overlapping syndrome with predominant primary biliary cirrhosis
- Chronic renal failure
- Hepatocellular carcinoma
- Neuropsychiatric disorders
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. Each participant will receive nutritional counseling once month during six months. | Dietary supplement | Autoimmune hepatitis (Cirrhotic), Autoimmune hepatitis (Non-cirrhotic) |
Primary outcome
Nutritional Status
Time frame: Participants will be assessed for six months
Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculated 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 assessed for six months
Quality of life
Time frame: Participants will be assessed for six 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 20 Aug 2014.
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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 principal investigator
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 Autoimmune Hepatitis and 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 5 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 20 Aug 2014. 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 assessed for six 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 20 Aug 2014.