The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

NACompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

January 21, 2021

Primary Completion Date

November 2, 2022

Study Completion Date

March 5, 2023

Conditions
CirrhosisAscitesLiver DiseasesFrailtySarcopeniaHepatic 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.

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

University of Michigan

OTHER

NCT04675775 - The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy. | Biotech Hunter | Biotech Hunter