High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy

NCT ID: NCT02418039

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-10
• Study Completion Date: 2021-07-26

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MHE and normal protein diet

Normal protein content (0.8 g/kg/day)

Group Type: PLACEBO_COMPARATOR

Normal protein

Intervention Type: DIETARY_SUPPLEMENT

A normal protein diet will be administrated in patients with MHE.

MHE and high protein diet

Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day)

Group Type: EXPERIMENTAL

High protein diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

High protein 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.

Intervention Type: DIETARY_SUPPLEMENT

Normal protein

A normal protein diet will be administrated in patients with MHE.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

hyperproteic diet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Segundo Moran Villota

Asociado B

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Segundo Moran, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

R-2014-785-007

Identifier Type: -

Identifier Source: org_study_id