The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial

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