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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Dietary supplement: Normal protein; Dietary supplement: High protein diet

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06725
      • Instituto Mexicano del Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: MHE and normal protein diet; Normal protein content (0.8 g/kg/day)	Dietary supplement: Normal protein; A normal protein diet will be administrated in patients with MHE.
Experimental: MHE and high protein diet; Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day)	Dietary supplement: 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.; Other Names: hyperproteic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reversal of minimal hepatic encephalopathy intervention)	Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
Incidence of hepatic encephalopathy	Number of patients that develop minimal hepatic encephalopathy after dietary intervention	1 month

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Actual): July 26, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 15, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Minimal hepatic encephalopathy
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Fibrosis; Brain Diseases, Metabolic; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: R-2014-785-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No