Effect of Brief Dietary Intervention on Ammonia Levels

Completed · Not applicable

Conditions studied: Cirrhosis, Hepatic Encephalopathy

In brief

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

Key facts

Study ID

NCT05376488

Run by

Hunter Holmes Mcguire Veteran Affairs Medical Center

People needed

30

Starts

2022-05-01

Expected to finish

2023-04-20

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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