Vegetable Proteins Versus Mixed Animal Proteins on the Outcome of Hepatic Encephalopathy

NCT06075875 | Unknown

• 1 other identifier: 45-2023
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• grade of hepatic encepalopathy

  if the vegetable proteins will improve the hepatic encephalopathy grade in comparison with animal proteins.

  48hours

Secondary Outcomes (2)

• length of stay

  during the study up to 24 weeks

• length of stay

  during the study up to one year

Study Arms (2)

control=mixed animal and vegetable proteins

ACTIVE COMPARATOR

mixed animal and vegetable proteins in the standard ratio (2/3:1/3; 60%:40% respectively) present in the nutritional menu over all hospitals in the general organization of teaching hospitals and institutes "GOTHI"; Egypt= as a control group.(average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).

Dietary Supplement: mixed animal and vegetable proteins

study= pure vegetable proteins

EXPERIMENTAL

pure vegetable proteins (a study group). (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).

Dietary Supplement: pure vegetable proteins

Interventions

mixed animal and vegetable proteins DIETARY_SUPPLEMENT

mixed animal and vegetable proteins in the standard ratio (2/3:1/3; 60%:40% respectively) present in the nutritional menu over all hospitals in the general organization of teaching hospitals and institutes "GOTHI"; Egypt= as a control group) and continued for at least 48hours and followed for five days. The vegetable diets will be prepared from the dietetic service of our institute;calories will be calculated for 30Kcal/Kg/day (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).

control=mixed animal and vegetable proteins

pure vegetable proteins DIETARY_SUPPLEMENT

pure vegetable proteins continued for at least 48hours and followed for five days. The vegetable diets will be prepared from the dietetic service of our institute;calories will be calculated for 30Kcal/Kg/day (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).

study= pure vegetable proteins

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• If they have contraindication for enteral nutrition e.g. intestinal obstruction, or active hematemesis.
• Patients who are on total parenteral nutrition

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead

Study Sites (1)

NHTMRI

Cairo, 4260010, Egypt

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Plant Proteins, Dietary

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Eman Ibrahim El-Desoki Mahmoud

CONTACT

+201227409501; eman18350@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow of intensive care medicine

Model Details: prospective, randomized, double blind,single-center study

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 10, 2023
• Study Start: December 23, 2023
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

EG (1)