Liver CirrhosisNCT02418039
High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy
A study testing High protein diet and Normal protein in people with Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. 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?
- High protein diet and Normal protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 10 Mar 2017to 26 Jul 2021
- 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
- Diagnosis of cirrhosis of any etiology
- Men and women between 18 and 70 years.
- Right-holders of the Mexican Social Security Institute
- Patients who agree to participate in the study and signed the informed consent
Who cannot join
- Recent history of alcohol abuse and/or drugs (less than 6 weeks).
- Illiterate
- Alcoholic cirrhosis
- History and/or diagnosis of overt hepatic encephalopathy
- Consumption of psychotropic medications (benzodiazepines, antiepileptics)
- Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements.
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- History of chronic renal disease or heart failure
- Patients with gastrointestinal bleeding
- History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests
- Diagnosis of bacterial overgrowth
- Diagnosis of liver cancer
- Patients with ophthalmologic disorders
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06725
About this study
Official title: Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial
A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. All patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. The supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.
Read the detailed description
The protein in the diet is a major source of ammonia in blood, which is considered one of the factors involved in the pathogenesis of hepatic encephalopathy. However ; it is also known than the restriction on the consumption of protein predisposes to depletion of muscle mass, and increase the risk to develop overt hepatic encephalopathy, due to the muscle role in the detoxification of ammonia in presence of liver failure. Currently, the type and amount of protein in the diet to treat minimal hepatic encephalopathy (MHE) is unknown. In this study, the investigators will administrated two types of protein content in patients with MHE: a high protein diet (1.5 g/kg/day) vs a normal protein diet (0.8 g/kg/day) during 1 month.
- Conditions
- Liver Cirrhosis
- Being tested
- High protein diet, Normal protein
- Keywords
- Minimal hepatic encephalopathy, Nutrition
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein dietDietary supplement
Also called hyperproteic diet
It has been suggested that administrating a high protein diet in patients with liver cirrhosis and with minimal hepatic encephalopathy could prevent the development of malnutrition, increase the detoxification of ammonia by the muscle to consequently delay the onset overt hepatic encephalopathy and prolong patient survival. However, information is scarce and inconclusive regarding the potential role of dietary protein in the prevention and treatment of minimal hepatic encephalopathy.
Normal proteinDietary supplement
A normal protein diet will be administrated in patients with MHE.
| Study group | Role | What they receive |
|---|---|---|
| MHE and normal protein diet | Placebo comparator | Normal protein content (0.8 g/kg/day) Receives: Dietary Supplement: Normal protein |
| MHE and high protein diet | Experimental | Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day) Receives: Dietary Supplement: High protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of minimal hepatic encephalopathy intervention)
Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention
Measured: 1 month
Secondary outcomes (2)
Nutritional Status
To evaluate the effect of dietary intervention on nutritional status. The nutritional status will be evaluated with the hand strength measured by a dynamometer. A value less than 30 kg will be consider as risk of malnutrition.
Measured: 1 month
Incidence of hepatic encephalopathy
Number of patients that develop minimal hepatic encephalopathy after dietary intervention
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study start10 Mar 2017
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Why it stopped: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico
- Investigators
- Segundo Moran, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418039
- Sponsor's protocol ID
- R-2014-785-007
- Status last verified
- Mar 2022
- First submitted
- 8 Apr 2015
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02418039
- Acronym / sponsor ID
- R-2014-785-007
- Conditions
- Liver Cirrhosis
- Keywords
- Minimal hepatic encephalopathy, Nutrition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 16 Apr 2015 (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.
A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. All patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. The supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.
Detailed description
The protein in the diet is a major source of ammonia in blood, which is considered one of the factors involved in the pathogenesis of hepatic encephalopathy. However ; it is also known than the restriction on the consumption of protein predisposes to depletion of muscle mass, and increase the risk to develop overt hepatic encephalopathy, due to the muscle role in the detoxification of ammonia in presence of liver failure. Currently, the type and amount of protein in the diet to treat minimal hepatic encephalopathy (MHE) is unknown. In this study, the investigators will administrated two types of protein content in patients with MHE: a high protein diet (1.5 g/kg/day) vs a normal protein diet (0.8 g/kg/day) during 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHE and normal protein diet | Placebo comparator | Dietary Supplement: Normal proteinNormal protein content (0.8 g/kg/day) |
| MHE and high protein diet | Experimental | Dietary Supplement: High protein dietPatients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cirrhosis of any etiology
- Men and women between 18 and 70 years.
- Right-holders of the Mexican Social Security Institute
- Patients who agree to participate in the study and signed the informed consent
Key exclusion criteria (12 listed)
- Recent history of alcohol abuse and/or drugs (less than 6 weeks).
- Illiterate
- Alcoholic cirrhosis
- History and/or diagnosis of overt hepatic encephalopathy
- Consumption of psychotropic medications (benzodiazepines, antiepileptics)
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 dietAlso: hyperproteic dietIt has been suggested that administrating a high protein diet in patients with liver cirrhosis and with minimal hepatic encephalopathy could prevent the development of malnutrition, increase the detoxification of ammonia by the muscle to consequently delay the onset overt hepatic encephalopathy and prolong patient survival. However, information is scarce and inconclusive regarding the potential role of dietary protein in the prevention and treatment of minimal hepatic encephalopathy. | Dietary supplement | MHE and high protein diet |
| Normal proteinA normal protein diet will be administrated in patients with MHE. | Dietary supplement | MHE and normal protein diet |
Primary outcome
Reversal of minimal hepatic encephalopathy intervention)
Time frame: 1 month
Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention
2 secondary outcomes
Nutritional Status
Time frame: 1 month
Incidence of hepatic encephalopathy
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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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.
Segundo Moran, MD principal investigator
Instituto Mexicano del Seguro Social
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 diet and Normal protein in people with Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico 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 12 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: stopped early, as of the sponsor's last update on 21 Mar 2022. 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 was stopped early (reason given: The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.). Results are not available in the source record.
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?
Reversal of minimal hepatic encephalopathy intervention) (time frame: 1 month). 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 21 Mar 2022.