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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.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHE and normal protein diet | Placebo Comparator | Normal protein content (0.8 g/kg/day) |
|
| MHE and high protein diet | Experimental | Patients with minimal hepatic encephalopathy will received a high protein diet (1.5 g/kg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of minimal hepatic encephalopathy intervention) | Number of patients who reverts the minimal hepatic encephalopathy after dietary intervention | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Segundo Moran, MD | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano del Seguro Social | Mexico City | Mexico City | 06725 | Mexico |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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|
|
| Normal protein | Dietary Supplement | A normal protein diet will be administrated in patients with MHE. |
|
Number of patients that develop minimal hepatic encephalopathy after dietary intervention |
| 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |