Liver CirrhosisNCT02022137
Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy
A study testing Red cereal bar, Green cereal bar and White cereal bar in people with Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Red cereal bar, Green cereal bar and White cereal bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2013to Mar 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
- Aged 18 to 70 years.
- Liver cirrhosis of any etiology.
- Presence of minimal hepatic encephalopathy.
- Presence of hepatic encephalopathy I
Who cannot join
- Hepatic encephalopathy II or III
- Use of antibiotics in the previous month.
- Presence of immunological diseases.
- Consumption of probiotics.
- Patients with hepato-renal diseases.
- Patients who do not agree to participate in the project.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
México, D.f., 1400
About this study
Official title: Evaluation of the Effect of a Cereal Bar With Added Agave Fructans or Lactitol or Lactose, in Patients With Minimal Hepatic Encephalopathy
As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.
Read the detailed description
Hepatic encephalopathy (HE) is a potentially reversible neuropsychiatric syndrome characterized by changes in cognitive function, behavior and personality of patients with chronic liver disease or cirrhosis. Increased concentration of ammonia is the main precipitant of encephalopathy and brain astrocytes are the main affected cells in the neuropathology of this disease. The toxicity of ammonia together with the neutrophil dysfunction and oxidative stress and inflammation secondary to infection, result in a progressive decline in quality of life and an increased risk of accidents for patients with this disease.
About 28% of patients with liver cirrhosis develop encephalopathy during the course of the disease and within this percentage, 84% will develop MHE. Currently, chronic liver diseases are the third leading cause of death in Mexico. The high prevalence suggests that HE could become a public health problem, with the 2020 projected figures of 1.5 million people with cirrhosis, which represents approximately 400 000 to 500 000 people with probable encephalopathy.
The usual treatment of MHE is the use of antibiotics or pro and prebiotics, these enhances the performance and quality of life of patients who have the disease. The general consensus has been using lactulose or lactitol as the first treatment options for MHE consistent with data from previous studies. However, the rate of adherence to treatment with lactulose and lactitol is low, especially in patients with MHE with no symptoms and lack of specific information about their problems, to adhere to medications that can cause diarrhea and flatulence.
In the last eight years functional ingredients have been studied as alternatives to the treatment of patients with MHE. In 2004, Liu et al showed that 25% chicory inulin (prebiotic) and this combined with probiotics improve the psychometric function of MHE patients. In similar studies conducted in 2007 and 2009 in which they used a formulation with a symbiotic fructo-oligosaccharides based chicory inulin and B. longum, showed improvement in psychometric tests applied to patients. In 2008, Bajaj et al showed that patients who consumed a yogurt with probiotics, showed significant changes in the degree of MHE.
As an alternative for treating the MHE we found Agave tequilana Weber fructans, which present prebiotic effect, besides having shown to improve the function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving the health and quality of life of patients with MHE.
- Conditions
- Liver Cirrhosis
- Being tested
- Red cereal bar, Green cereal bar, White cereal bar
- Keywords
- Minimal hepatic encephalopathy, Hepatic encephalopathy
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cereal barDietary supplement
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
Green cereal barDietary supplement
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
White cereal barDietary supplement
Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
| Study group | Role | What they receive |
|---|---|---|
| Red cereal bar | Experimental | It includes the intervention of the red cereal bar for the designation of the group. Receives: Dietary Supplement: Red cereal bar |
| Green cereal bar | Placebo comparator | It includes the intervention of the green cereal bar for the designation of the group. Receives: Dietary Supplement: Green cereal bar |
| White cereal bar | Active comparator | It includes the intervention of the white cereal bar for the designation of the group. Receives: Dietary Supplement: White cereal bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal hepatic encephalopathy
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
Measured: 2 months
Secondary outcomes (1)
Nutritional Status
Measured with the following parameters:body weight and height (to calculate BMI), triceps skinfold and mid-arm circumference (to calculate mid-arm muscle circumference, and bioelectrical impedance vector analysis.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT02022137
- Sponsor's protocol ID
- GAS-588-12/13-1
- Status last verified
- Jun 2016
- First submitted
- 16 Dec 2013
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of the Effect of a Cereal Bar With Added Agave Fructans or Lactitol or Lactose, in Patients With Minimal Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT02022137
- Acronym / sponsor ID
- GAS-588-12/13-1
- Conditions
- Liver Cirrhosis
- Keywords
- Minimal hepatic encephalopathy, Hepatic encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Dec 2013 (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.
As an alternative for the treatment of Minimal Hepatic Encephalopathy (MHE) Agave fructans have shown prebiotic effects, and have shown to improve function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving health and quality of life of patients with MHE.
Detailed description
Hepatic encephalopathy (HE) is a potentially reversible neuropsychiatric syndrome characterized by changes in cognitive function, behavior and personality of patients with chronic liver disease or cirrhosis. Increased concentration of ammonia is the main precipitant of encephalopathy and brain astrocytes are the main affected cells in the neuropathology of this disease. The toxicity of ammonia together with the neutrophil dysfunction and oxidative stress and inflammation secondary to infection, result in a progressive decline in quality of life and an increased risk of accidents for patients with this disease.
About 28% of patients with liver cirrhosis develop encephalopathy during the course of the disease and within this percentage, 84% will develop MHE. Currently, chronic liver diseases are the third leading cause of death in Mexico. The high prevalence suggests that HE could become a public health problem, with the 2020 projected figures of 1.5 million people with cirrhosis, which represents approximately 400 000 to 500 000 people with probable encephalopathy.
The usual treatment of MHE is the use of antibiotics or pro and prebiotics, these enhances the performance and quality of life of patients who have the disease. The general consensus has been using lactulose or lactitol as the first treatment options for MHE consistent with data from previous studies. However, the rate of adherence to treatment with lactulose and lactitol is low, especially in patients with MHE with no symptoms and lack of specific information about their problems, to adhere to medications that can cause diarrhea and flatulence.
In the last eight years functional ingredients have been studied as alternatives to the treatment of patients with MHE. In 2004, Liu et al showed that 25% chicory inulin (prebiotic) and this combined with probiotics improve the psychometric function of MHE patients. In similar studies conducted in 2007 and 2009 in which they used a formulation with a symbiotic fructo-oligosaccharides based chicory inulin and B. longum, showed improvement in psychometric tests applied to patients. In 2008, Bajaj et al showed that patients who consumed a yogurt with probiotics, showed significant changes in the degree of MHE.
As an alternative for treating the MHE we found Agave tequilana Weber fructans, which present prebiotic effect, besides having shown to improve the function of the digestive system, control and induce glycemic effect satiety. Therefore the impact of the fermentation of such prebiotic in the gut may contribute to improving the health and quality of life of patients with MHE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red cereal bar | Experimental | Dietary Supplement: Red cereal barIt includes the intervention of the red cereal bar for the designation of the group. |
| Green cereal bar | Placebo comparator | Dietary Supplement: Green cereal barIt includes the intervention of the green cereal bar for the designation of the group. |
| White cereal bar | Active comparator | Dietary Supplement: White cereal barIt includes the intervention of the white cereal bar for the designation of the group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 70 years.
- Liver cirrhosis of any etiology.
- Presence of minimal hepatic encephalopathy.
- Presence of hepatic encephalopathy I
Key exclusion criteria (6 listed)
- Hepatic encephalopathy II or III
- Use of antibiotics in the previous month.
- Presence of immunological diseases.
- Consumption of probiotics.
- Patients with hepato-renal diseases.
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 |
|---|---|---|
| Red cereal barConsumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber. | Dietary supplement | Red cereal bar |
| Green cereal barConsumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber. | Dietary supplement | Green cereal bar |
| White cereal barConsumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber. | Dietary supplement | White cereal bar |
Primary outcome
Minimal hepatic encephalopathy
Time frame: 2 months
Assessed by psychometric Hepatic Encephalopathy (PHES) and Critical Flicker Frequency (CFF)
1 secondary outcome
Nutritional Status
Time frame: 2 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 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 Red cereal bar, Green cereal bar and White cereal bar in people with Liver 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 4 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. Some participants in this study may receive a placebo. 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?
Minimal hepatic encephalopathy (time frame: 2 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.