High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalop… (NCT02418039) | Clinical Trial Compass
TerminatedNot Applicable
High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy
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.
Mexico42 participantsStarted 2017-03-10
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reversal of minimal hepatic encephalopathy intervention)
Timeframe: 1 month
Trial details
NCT IDNCT02418039
SponsorCoordinación de Investigación en Salud, Mexico