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

NCT02418039 | Terminated

• 1 other identifier: R-2014-785-007
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Minimal hepatic encephalopathy; Nutrition

Outcome Measures

Primary Outcomes (1)

• Reversal of minimal hepatic encephalopathy intervention)

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

  1 month

Secondary Outcomes (2)

• Nutritional Status

  1 month

• Incidence of hepatic encephalopathy

  1 month

Study Arms (2)

MHE and normal protein diet

PLACEBO COMPARATOR

Normal protein content (0.8 g/kg/day)

Dietary Supplement: Normal protein

MHE and high protein diet

EXPERIMENTAL

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

Dietary Supplement: High protein diet

Interventions

High protein diet 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.

Also known as: hyperproteic diet

MHE and high protein diet

Normal protein DIETARY_SUPPLEMENT

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

MHE and normal protein diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06725, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Segundo Moran, MD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asociado B

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 16, 2015
• Study Start: March 10, 2017
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

ME (1)