Clinical trial NCT04675775: The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
Official title: Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Ascites
Liver Diseases
Frailty
Sarcopenia
Hepatic Encephalopathy
Keywords: Nutrition
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits
timeFrame: up to 27 weeks post enrollment
measure: Participant Adherence Rate to Medically-Tailored Meals (MTM)
timeFrame: up to 11 weeks post enrollment
Secondary outcomes:
measure: Proportion of Participants Who Completed All Study Assessments and Procedures
timeFrame: up to 27 weeks post enrollment
measure: Eligible Candidates Who Enrolled After Screening
timeFrame: approximately 1 year (enrollment period)
measure: The Percentage of Enrolled Participants Who Dropped Out of Study
timeFrame: up to 27 weeks
measure: Time Required to Complete Assessments
timeFrame: Up to 90 minutes
Other outcomes:
measure: The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews
timeFrame: up to 11 weeks post enrollment
measure: Change is EncephalApp - Stroop Score
timeFrame: baseline, up to 13 weeks
measure: Change in One Minute Animal Naming Test (ANT)
timeFrame: baseline, up to 27 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elliot Tapper, MD
role: PRINCIPAL_INVESTIGATOR
References: