The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
This study is being completed for patients with cirrhosis, including patients with a prior
 history of hepatic encephalopathy (HE) to evaluate the feasibility and benefits of
 medically-tailored meals as an intervention.

 Patients will be enrolled from the University of Michigan and will complete the baseline
 assessments in-person or remotely. In addition participants will complete study related
 materials before, during and after treatment with medically-tailored meals (MTM). After
 completing the study meals, participants will return for follow-up or have this visit
 completed remotely as well as have an observational period for 12 more weeks.
Inclusion Criteria:

 -  Diagnosis of cirrhosis will be based upon:

 1. liver biopsy, OR

 2. history of cirrhosis complication: ascites, variceal bleeding, hepatic
 encephalopathy, OR

 3. 2 of the following 4 criteria:

 1. Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI)
 findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices,
 ascites)

 2. Fibroscan liver stiffness score >13 kilopascals (kPa)

 3. Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI)
 >2.0

 4. CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal
 varices

 -  Patients with history of > grade 2 HE within 180 days of enrollment based on review of
 clinical documentation verifying the event. If a description of HE symptoms is
 provided in clinical documentation, but it is unclear if it meets Grade 2 criteria,
 the principal investigator will assess the clinical documentation and provide an HE
 grade.

 Exclusion Criteria:

 -  Non-English speaking

 -  Model for End-Stage Liver Disease (MELD) Score > 20

 -  Pregnancy (self-reported)

 -  Unable or unwilling to provide consent

 -  History of liver transplant

 -  Current or planned admission to a nursing facility

 -  Serum creatinine > 2.0 milligrams per deciliter (mg/dL) (with the exception that we
 will include patients with a serum creatinine > 2.0 mg/dL if they are receiving
 hemodialysis)

 -  Disorientation at the time of enrollment

 -  Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with
 Child-Turcotte-Pugh (CTP) Class C

 -  History of eating disorder