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
Sponsored by
About this trial
This is an interventional supportive care trial for Cirrhosis
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.
Sites / Locations
- Hunter Holmes McGuire VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
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Effect of Brief Dietary Intervention on Ammonia Levels
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