Effect of Brief Dietary Intervention on Ammonia Levels

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376488
• Other study ID #: BAJAJ030
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: September 2023
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cirrhosis

2. Able and willing to voluntarily complete the informed consent process

3. Available for and agree to all study procedures

4. Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview

Exclusion Criteria:

1. MELD score > 23

2. Unclear diagnosis of cirrhosis

3. History of liver transplant

4. Body mass index < 18.5 or = 40 kg/m2

5. Prior transjugular intrahepatic portosystemic shunt placement

6. Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment

7. For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE)

8. Current use of valproate, corticosteroids, or cytotoxic drugs.

9. 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.

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Other:
• One meal
One meal given to assess impact on ammonia levels serially

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous ammonia level	Change in these levels hourly from baseline	3 hours
Secondary	Venous ammonia level	Change in these levels from baseline to hour 1	1 hour
Secondary	Venous ammonia level	Change in these levels from baseline to hour 2	2 hours
Secondary	Venous ammonia level	Change in these levels from baseline to hour 3	3 hours