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Medically-tailored meals (MTM) for Encephalopathy

N/A

Waitlist Available

Led By Elliot Tapper, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year (enrollment period)

Awards & highlights

Study Summary

This trial is looking at whether medically-tailored meals can help patients with cirrhosis, including those who have had hepatic encephalopathy in the past.

Eligible Conditions

Liver Encephalopathy
Frailty
Liver Disease
Ascites
Liver Cirrhosis
Sarcopenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year (enrollment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year (enrollment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year (enrollment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits

Participant Adherence Rate to Medically-Tailored Meals (MTM)

Secondary outcome measures

Eligible Candidates Who Enrolled After Screening

Proportion of Participants Who Completed All Study Assessments and Procedures

The Percentage of Enrolled Participants Who Dropped Out of Study

+1 more

Other outcome measures

Change in One Minute Animal Naming Test (ANT)

Change is EncephalApp - Stroop Score

The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews

Trial Design

1Treatment groups

Experimental Treatment

Group I: Medically-tailored mealsExperimental Treatment3 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Protein supplements

2021

N/A

~20

Nutrition education handout

2021

N/A

~20

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Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,908 Total Patients Enrolled

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,041 Total Patients Enrolled

Elliot Tapper, MDPrincipal InvestigatorUniversity of Michigan

4 Previous Clinical Trials

324 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for participants in this trial?

"Unfortunately, this medical trial is no longer accepting candidates. It was originally posted on January 21st 2021 and the most recent edits were made on November 2nd 2022. Nonetheless, there are still 729 other clinical studies actively recruiting patients at present."

Answered by AI

What objectives is this clinical experiment hoping to fulfill?

"The primary and secondary objectives of this 27-week long trial are to measure subject adherence to Medically-Tailored Meals (MTM) by observing the proportion of participants that consume ≥75% meals plus an evening snack. Additionally, changes in cognitive function will be tracked through The Animal Naming Test (ANT), EncephalApp's Stroop Score, as well as dropout rates due to withdrawal or lost follow-up."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Elliot B. Tapper 2021. "The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04675775.