CompletedNot Applicable

Effect of Brief Dietary Intervention on Ammonia Levels

United States30 participantsStarted 2022-05-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Venous ammonia level

Timeframe: 3 hours

Trial details

NCT IDNCT05376488

SponsorHunter Holmes Mcguire Veteran Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2022-12-20

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