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

Liver Cirrhosis Clinical Trial

Official title:

Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02418039
• Other study ID #: R-2014-785-007
• Status: Terminated
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: July 26, 2021

Study information

• Verified date: March 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

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

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of minimal hepatic encephalopathy intervention)	Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention	1 month
Secondary	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
Secondary	Incidence of hepatic encephalopathy	Number of patients that develop minimal hepatic encephalopathy after dietary intervention	1 month