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

NCT ID: NCT06075875

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-23

Study Completion Date

2025-01-31

Brief Summary

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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

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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 blood glucose will be monitored in the first 72hours. Follow up arterial ammonia will e on day zero (start of regimen) and day three.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, double blind,single-center study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control=mixed animal and vegetable proteins

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).

Group Type ACTIVE_COMPARATOR

mixed animal and vegetable proteins

Intervention Type 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).

study= pure vegetable proteins

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

Group Type EXPERIMENTAL

pure vegetable proteins

Intervention Type 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).

Interventions

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mixed animal and vegetable proteins

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

pure vegetable proteins

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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hepatology & Tropical Medicine Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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ICU

fellow of intensive care medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NHTMRI

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Eman Ibrahim El-Desoki Mahmoud

Role: CONTACT

Phone: +201227409501

Email: [email protected]

Other Identifiers

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45-2023

Identifier Type: -

Identifier Source: org_study_id