The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

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.

Conditions

• Cirrhosis
• Ascites
• Liver Diseases
• Frailty
• Sarcopenia
• Hepatic Encephalopathy

Interventions

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Elliot Tapper, MD · University of Michigan

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-21

Primary Completion

2022-11-02

Completion

2023-03-05

Countries

• United States

Study Locations