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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Hepatic Encephalopathy; Frailty; Cirrhosis; Sarcopenia; Ascites
• Intervention / Treatment: Other: Medically-tailored meals (MTM); Dietary supplement: Protein supplements; Behavioral: Nutrition education handout

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Medically-tailored meals; 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).

Other: Medically-tailored meals (MTM); After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals.; Dietary supplement: Protein supplements; A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk. This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving.; Behavioral: Nutrition education handout; A standardized nutrition education handout containing instructions on following a high-protein and sodium restricted diet (depending on the presence of ascites) will be given as part of Standard of Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits	Overall participant retention rate based on proportion of participants who completed all study visits	up to 27 weeks post enrollment
Participant Adherence Rate to Medically-Tailored Meals (MTM)	The participant adherence rate to MTM based on proportion of participants who consumed ≥75% of delivered meals and evening snack	up to 11 weeks post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Completed All Study Assessments and Procedures	The number of participants who completed all study assessments and procedures during each study visit compared to the number of participants who did not complete all study assessments and procedures.	up to 27 weeks post enrollment
Eligible Candidates Who Enrolled After Screening	Results show the participants who enrolled in the trial following determination of the total number of candidates who were screened and determined to be eligible to participate in the trial.	approximately 1 year (enrollment period)
The Percentage of Enrolled Participants Who Dropped Out of Study	The percentage of enrolled participants who dropped out of either study stage before the final study visit due to withdrawal by participant or lost to follow-up, and not due to death, withdrawal by study staff or principal investigator discretion.	up to 27 weeks
Time Required to Complete Assessments	Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.	Up to 90 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews	The proportion of participants who complete all 24-hour Diet Recall interviews compared to the number of participants who did not complete all 24-Hour Diet Recall interviews.	up to 11 weeks post enrollment
Change is EncephalApp - Stroop Score	This was a computerized, timed test of attention conducted on an Interactive Personal Application Device (iPad) or smart device by a phone application that asked participants to identify the color of words. The score was the sum of the time it took to complete color-word concordance and color-word discordance. A score of less than 190 was considered 'normal' cognitive function. Participants who were color-blind were excluded from performing this test.	baseline, up to 13 weeks
Change in One Minute Animal Naming Test (ANT)	The participants listed as many unique animals as possible in 60 seconds.	baseline, up to 27 weeks

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Elliot Tapper, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): March 5, 2023

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Brain Diseases, Metabolic; Liver Diseases; Frailty; Sarcopenia; Hepatic Encephalopathy; Brain Diseases; Ascites
• Other Study ID Numbers: HUM00168821; P30AG024824 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No