Hepatic Encephalopathy Clinical Trial
Official title:
Comparative Study Between Vegetable Proteins, and Mixed Animal Proteins on the Outcome of Hepatic Encephalopathy Patients in ICU and Wards
Vegetables are thought to be beneficial not only because of their high content of fiber, which promotes bacterial fermentation and decreases colonic transit time, decreasing ammonia absorption from the gut, but also because of their high BCAA content, low methionine and tryptophan contents, and the induction of gut microbiota which, in turn, increases fecal nitrogen excretion. Also the fact supporting the underlying rationale for the use of vegetable proteins is that dietary fiber contributes to the improvement of glycemic control in these patients. Smaller sample studies also support the idea that vegetable based protein diets have better effect on cognition in patients with HE; in these studies vegetable protein diet was compared to meat protein diet and patients with HE showed improvement in cognition on former diets. However, no positive effects were shown by Shaw or Chiarino. Similarly, another older single blind crossover study (n=10) showed that as compared to meat proteins, vegan diet has a better effect on mental status as determined on psychometric testing in patients with HE. As a result of the limited studies and small number of participants of the effect of vegetable proteins on HE, the purpose of this study is to investigate the effects of a vegetable versus mixed animal and vegetable protein diet on hepatic encephalopathy.
Status | Not yet recruiting |
Enrollment | 196 |
Est. completion date | January 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults aged =18years old - admitted to the intensive care unit or wards of the National Hepatology and Tropical Medicine Research Institute (NHTMRI) who have or developed hepatic encephalopathy and have no contraindication for enteral nutrition Exclusion Criteria: - If they have contraindication for enteral nutrition e.g. intestinal obstruction, or active hematemesis. - Patients who are on total parenteral nutrition |
Country | Name | City | State |
---|---|---|---|
Egypt | NHTMRI | Cairo |
Lead Sponsor | Collaborator |
---|---|
National Hepatology & Tropical Medicine Research Institute |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | grade of hepatic encepalopathy | if the vegetable proteins will improve the hepatic encephalopathy grade in comparison with animal proteins. | 48hours | |
Secondary | length of stay | ICU ength of stay | during the study up to 24 weeks | |
Secondary | length of stay | hospital stay | during the study up to one year |
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