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

Not Applicable

Terminated

• Conditions: Liver Cirrhosis
• Interventions: Dietary Supplement: Normal protein; Dietary Supplement: High protein diet

• Registration Number: NCT02418039
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2017-03-10
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MHE and normal protein diet	Normal protein	Normal protein content (0.8 g/kg/day)
MHE and high protein diet	High protein diet	Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day)

Primary Outcome Measures

Name	Time	Method
Reversal of minimal hepatic encephalopathy intervention)	1 month	Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention

Secondary Outcome Measures

Name	Time	Method
Nutritional Status	1 month	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.
Incidence of hepatic encephalopathy	1 month	Number of patients that develop minimal hepatic encephalopathy after dietary intervention

Trial Locations

Locations (1)

Instituto Mexicano del Seguro Social; 🇲🇽 Mexico, Distrito Federal, Mexico