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Effect of Brief Dietary Intervention on Ammonia Levels

Primary Purpose

Cirrhosis, Hepatic Encephalopathy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

One meal

About this trial

This is an interventional supportive care trial for Cirrhosis

Eligibility Criteria

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

Inclusion Criteria:

Cirrhosis
Able and willing to voluntarily complete the informed consent process
Available for and agree to all study procedures
Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview

Exclusion Criteria:

MELD score > 23
Unclear diagnosis of cirrhosis
History of liver transplant
Body mass index < 18.5 or ≥ 40 kg/m2
Prior transjugular intrahepatic portosystemic shunt placement
Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment
For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE)
Current use of valproate, corticosteroids, or cytotoxic drugs.
Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.

Sites / Locations

Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Meal type A

Meal type B

Meal type C

Arm Description

Meal type A: equicaloric meal as meal type B and C with differing constituents

Meal type B: equicaloric meal as meal type A and C with differing constituents

Meal type C: equicaloric meal as meal type B and A with differing constituents

Outcomes

Primary Outcome Measures

Venous ammonia level

Change in these levels hourly from baseline

Secondary Outcome Measures

Venous ammonia level

Change in these levels from baseline to hour 1

Venous ammonia level

Change in these levels from baseline to hour 2

Venous ammonia level

Change in these levels from baseline to hour 3

Full Information

NCT ID

NCT05376488

First Posted

May 11, 2022

Last Updated

September 20, 2023

Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05376488

Brief Title

Effect of Brief Dietary Intervention on Ammonia Levels

Official Title

Characterization of Venous Ammonia Levels in Fasted and Fed State in Patients With Cirrhosis After Vegetarian, Vegan and Non-Vegetarian Meals

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 20, 2022 (Actual)

Study Completion Date

April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals. The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study. Total duration=4 hours

Detailed Description

Patient will be instructed to collect stool for baseline assessments. After a fast (>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous ammonia and blood and urine for metabolomics and blood microbiome. Spot ammonia and blood for metabolomics and microbiome will be collected from repeat samples at 1h and 2 hrs after a standardized meals from the three groups of protein meals. Urine will also be collected for metabolomics during the observation period. On the day of the study, patients will be asked to complete a standard food frequency questionnaire encompassing meals over 3 days prior to the study. Subjects will be randomly assigned into 3 groups (meal types A, B and C) with the standardized meal that contains 20gm of protein. All subjects are expected to consume it in its entirety. Subjects are not allowed to eat anything else until the end of the study. Subjects will be observed in the unit for a total of 3 hours after the standardized meal to ensure no symptoms related to potential elevated ammonia emerge. Any adverse events will be treated according to standard clinical routine.

6. Conditions and Keywords

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

Cirrhosis, Hepatic Encephalopathy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized single blind

Masking

ParticipantOutcomes Assessor

Masking Description

Patients are blinded

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meal type A

Arm Type

Active Comparator

Arm Description

Meal type A: equicaloric meal as meal type B and C with differing constituents

Arm Title

Meal type B

Arm Type

Active Comparator

Arm Description

Meal type B: equicaloric meal as meal type A and C with differing constituents

Arm Title

Meal type C

Arm Type

Experimental

Arm Description

Meal type C: equicaloric meal as meal type B and A with differing constituents

Intervention Type

Other

Intervention Name(s)

One meal

Intervention Description

One meal given to assess impact on ammonia levels serially

Primary Outcome Measure Information:

Title

Venous ammonia level

Description

Change in these levels hourly from baseline

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Venous ammonia level

Description

Change in these levels from baseline to hour 1

Time Frame

1 hour

Title

Venous ammonia level

Description

Change in these levels from baseline to hour 2

Time Frame

2 hours

Title

Venous ammonia level

Description

Change in these levels from baseline to hour 3

Time Frame

3 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cirrhosis Able and willing to voluntarily complete the informed consent process Available for and agree to all study procedures Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview Exclusion Criteria: MELD score > 23 Unclear diagnosis of cirrhosis History of liver transplant Body mass index < 18.5 or ≥ 40 kg/m2 Prior transjugular intrahepatic portosystemic shunt placement Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE) Current use of valproate, corticosteroids, or cytotoxic drugs. Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jasmohan Bajaj

Organizational Affiliation

Hunter Holmes McGuire VAMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hunter Holmes McGuire VA Medical Center

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Brief Dietary Intervention on Ammonia Levels

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