search
Back to results

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

Primary Purpose

Hepatic Encephalopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mixed animal and vegetable proteins
pure vegetable proteins
Sponsored by
National Hepatology & Tropical Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NHTMRI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control=mixed animal and vegetable proteins

study= pure vegetable proteins

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

length of stay
ICU ength of stay
length of stay
hospital stay

Full Information

First Posted
August 29, 2023
Last Updated
October 4, 2023
Sponsor
National Hepatology & Tropical Medicine Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT06075875
Brief Title
Vegetable Proteins Versus Mixed Animal Proteins on the Outcome of Hepatic Encephalopathy
Official Title
Comparative Study Between Vegetable Proteins, and Mixed Animal Proteins on the Outcome of Hepatic Encephalopathy Patients in ICU and Wards
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
After approval by NHTMRI-IRB Ethical Committee.All demographic data will be obtained including the patients age, sex,associated co-morbidities (diabetes mellitus & hypertension), cause of hepatic encephalopathy, grade of hepatic encephalopathybythe West Haven criteria (WHC),14Child-Pugh score, Model for end stage liver disease (MELD) score, and subjective global assessment (SGA). All patients will receive the routine medical supportive treatment of hepatic encephalopathy in the form of rectal enemas, oral non-absorbable disaccharides (Lactulose), non-absorbable antibacterial (Rifaximin). All patients will receive enteral nutrition either oral if tolerated (HE grade I/II) or through nasogastric tubes (if intolerant; HE grade III/IV). Patients were assessed for 24 hours for tolerance of enteral feeding. Patients were randomized to receiveeither diets containingpure vegetable proteins (a study group) versus the 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). Follow up daily for the degree of hepatic encephalopathy by WHC criteria will be recorded.Complete blood counts, urea and arterial ammonia levels, and blood glucose will be monitored in the first 72hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, double blind,single-center study
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control=mixed animal and vegetable proteins
Arm Type
Active Comparator
Arm Description
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).
Arm Title
study= pure vegetable proteins
Arm Type
Experimental
Arm Description
pure vegetable proteins (a study group). (average 2000Kcal) and proteins 1.2g/Kg/day15 (average 84gm).
Intervention Type
Dietary Supplement
Intervention Name(s)
mixed animal and vegetable proteins
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
pure vegetable proteins
Intervention Description
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).
Primary Outcome Measure Information:
Title
grade of hepatic encepalopathy
Description
if the vegetable proteins will improve the hepatic encephalopathy grade in comparison with animal proteins.
Time Frame
48hours
Secondary Outcome Measure Information:
Title
length of stay
Description
ICU ength of stay
Time Frame
during the study up to 24 weeks
Title
length of stay
Description
hospital stay
Time Frame
during the study up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Ibrahim El-Desoki Mahmoud
Phone
+201227409501
Email
eman18350@gmail.com
Facility Information:
Facility Name
NHTMRI
City
Cairo
ZIP/Postal Code
4260010
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs