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

Primary Purpose

Liver Cirrhosis

Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
High protein diet
Normal protein
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Minimal hepatic encephalopathy, Nutrition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

MHE and normal protein diet

MHE and high protein diet

Arm Description

Normal protein content (0.8 g/kg/day)

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

Outcomes

Primary Outcome Measures

Reversal of minimal hepatic encephalopathy intervention)
Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention

Secondary Outcome Measures

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.
Incidence of hepatic encephalopathy
Number of patients that develop minimal hepatic encephalopathy after dietary intervention

Full Information

First Posted
April 8, 2015
Last Updated
March 7, 2022
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02418039
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Minimal hepatic encephalopathy, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MHE and normal protein diet
Arm Type
Placebo Comparator
Arm Description
Normal protein content (0.8 g/kg/day)
Arm Title
MHE and high protein diet
Arm Type
Experimental
Arm Description
Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein diet
Other Intervention Name(s)
hyperproteic diet
Intervention Description
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
Intervention Name(s)
Normal protein
Intervention Description
A normal protein diet will be administrated in patients with MHE.
Primary Outcome Measure Information:
Title
Reversal of minimal hepatic encephalopathy intervention)
Description
Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Nutritional Status
Description
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.
Time Frame
1 month
Title
Incidence of hepatic encephalopathy
Description
Number of patients that develop minimal hepatic encephalopathy after dietary intervention
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Segundo Moran, MD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06725
Country
Mexico

12. IPD Sharing Statement

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

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