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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal type A | Active Comparator | Meal type A: equicaloric meal as meal type B and C with differing constituents |
|
| Meal type B | Active Comparator | Meal type B: equicaloric meal as meal type A and C with differing constituents |
|
| Meal type C | Experimental | Meal type C: equicaloric meal as meal type B and A with differing constituents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One meal | Other | One meal given to assess impact on ammonia levels serially |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous ammonia level | Change in these levels hourly from baseline | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Venous ammonia level | Change in these levels from baseline to hour 1 | 1 hour |
| Venous ammonia level | Change in these levels from baseline to hour 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasmohan Bajaj | Hunter Holmes McGuire VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2022 | Oct 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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Randomized single blind
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Patients are blinded
| 2 hours |
| Venous ammonia level | Change in these levels from baseline to hour 3 | 3 hours |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |