NCT04675775

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Completed NA Results posted Last updated 6 March 2024

What this trial tests

NA trial testing Medically-tailored meals (MTM) in Cirrhosis in 17 participants. Completed in 5 March 2023.

Timeline

21 January 2021

Primary endpoint
2 November 2022

5 March 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	21 January 2021
Primary completion	2 November 2022
Estimated completion	5 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Medically-tailored meals (MTM)
• Protein supplements
• Nutrition education handout

Conditions studied

• Cirrhosis — all drugs for Cirrhosis →
• Ascites — all drugs for Ascites →
• Liver Diseases — all drugs for Liver Diseases →
• Frailty — all drugs for Frailty →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Cirrhosis or Ascites. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits Primary · up to 27 weeks post enrollment

Overall participant retention rate based on proportion of participants who completed all study visits

Group	Value	95% CI
Medically-tailored Meals	10

Participant Adherence Rate to Medically-Tailored Meals (MTM) Primary · up to 11 weeks post enrollment

The participant adherence rate to MTM based on proportion of participants who consumed ≥75% of delivered meals and evening snack

Group	Value	95% CI
Medically-tailored Meals	10

Proportion of Participants Who Completed All Study Assessments and Procedures Secondary · up to 27 weeks post enrollment

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.

Group	Value	95% CI
Medically-tailored Meals	8

Eligible Candidates Who Enrolled After Screening Secondary · approximately 1 year (enrollment period)

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.

Group	Value	95% CI
Medically-tailored Meals	17

The Percentage of Enrolled Participants Who Dropped Out of Study Secondary · up to 27 weeks

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.

Group	Value	95% CI
Medically-tailored Meals	7

Time Required to Complete Assessments Secondary · Up to 90 minutes

Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.

Group	Value	95% CI
Medically-tailored Meals	43.27	± 21.44

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 27 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Medically-tailored Meals

Serious: 5/17 (29%)

Deaths: 2/17

Serious adverse events (1 terms)

Reaction	System	Medically-tailored Meals
Exacerbation of cirrhosis	Hepatobiliary disorders	—

Most-reported serious reactions: Exacerbation of cirrhosis.

Data from ClinicalTrials.gov NCT04675775 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Treatment Options for Sarcopenia in Chronic Liver Disease.
   Kim Y. · · 2021 · cited 17× · PMID 33803020 · DOI 10.3390/life11030250
2. Medically Tailored Meals for Patients With Cirrhosis and Hepatic Encephalopathy: The BRAINFOOD Proof-of-concept Trial.
   Tapper EB, Saleh ZM, Nikirk S, Bajaj J, et al · · 2024 · cited 6× · PMID 38882178 · DOI 10.1016/j.jceh.2024.101439