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

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ClinicalTrials.gov Identifier: NCT02418039
Recruitment Status : Recruiting
First Posted : April 16, 2015
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Segundo Moran Villota, 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Dietary Supplement: High protein diet Dietary Supplement: Normal protein Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy. Double-blind Clinical Trial
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019


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 Name: hyperproteic diet




Primary Outcome Measures :
  1. Reversal of minimal hepatic encephalopathy (number of patients who reverts the minimal hepatic encephalopathy after dietary intervention) [ Time Frame: 1 month ]
    Analyze the number of patients who reverts the minimal hepatic encephalopathy after dietary intervention


Secondary Outcome Measures :
  1. Nutritional Status [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418039


Contacts
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Contact: Segundo Moran, MD 525556276900 ext 22363 segundomoran@hotmail.com
Contact: Aline Mina, Nutr 525556276900 ext 22363 aline_mina@hotmail.com

Locations
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Mexico
Instituto Mexicano del Seguro Social Recruiting
Mexico, Distrito Federal, Mexico, 06725
Contact: Segundo Moran, MD    525556276900 ext 22363    segundomoran@hotmail.com   
Contact: Aline Mina, Nut MSc    525556276900 ext 22363    aline_mina@hotmail.com   
Principal Investigator: Segundo Moran, M.D.         
Sub-Investigator: Nayeli Ortiz, M.D.         
Sub-Investigator: Aline Mina, Nutr         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: Segundo Moran, MD Instituto Mexicano del Seguro Social

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Responsible Party: Segundo Moran Villota, Asociado B, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02418039     History of Changes
Other Study ID Numbers: R-2014-785-007
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico:
Minimal hepatic encephalopathy
Nutrition
Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases