Clinical trial NCT02418039: High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy
Official title: Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cirrhosis
Keywords: Minimal hepatic encephalopathy
Nutrition
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2015-04-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reversal of minimal hepatic encephalopathy intervention)
timeFrame: 1 month
Secondary outcomes:
measure: Nutritional Status
timeFrame: 1 month
measure: Incidence of hepatic encephalopathy
timeFrame: 1 month
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Segundo Moran, MD
role: PRINCIPAL_INVESTIGATOR
References: