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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
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.
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.
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.
University of Michigan
Ann Arbor, Michigan, United States
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
Time frame: 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
Time frame: up to 11 weeks post enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 90 minutes
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