The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

University of Michigan

Status: Completed

Conditions: Hepatic Encephalopathy; Cirrhosis; Frailty; Sarcopenia; Liver Diseases; Ascites

Treatments: Behavioral: Nutrition education handout; Other: Medically-tailored meals (MTM); Dietary Supplement: Protein supplements

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04675775

P30AG024824 (U.S. NIH Grant/Contract)

HUM00168821

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Medically-tailored meals

Experimental group

Description:

Participants will receive meals that adhere to their specified nutritional targets dependent upon their cirrhosis complication of hepatic encephalopathy (HE) and/or ascites. Participants with HE will receive high-protein (approximately 1 gram of medication per kilogram of the body weight (1g/kg/day) and high-calorie (approximately 30c/kg/day) meals. Participants with HE and ascites will receive high-protein and high-calorie meals that are also low-sodium (less than or equal to 2000 milligrams a day).

Treatment:

Behavioral: Nutrition education handout

Dietary Supplement: Protein supplements

Other: Medically-tailored meals (MTM)