N/A
N=17
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
Cirrhosis · Ascites · Liver Diseases · Frailty · Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT04675775 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
Mar 2024
Primary outcome: Primary: Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medically-tailored meals (MTM) (Other); Protein supplements (Dietary_supplement); Nutrition education handout (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits |
10 | — |
| PRIMARY Participant Adherence Rate to Medically-Tailored Meals (MTM) |
10 | — |
| SECONDARY Proportion of Participants Who Completed All Study Assessments and Procedures |
8 | — |
| SECONDARY Eligible Candidates Who Enrolled After Screening |
17 | — |
| SECONDARY The Percentage of Enrolled Participants Who Dropped Out of Study |
7 | — |
| SECONDARY Time Required to Complete Assessments |
43.27 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cirrhosis will be based upon:
- liver biopsy, OR
- history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
- 2 of the following 4 criteria:
- Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
- Fibroscan liver stiffness score >13 kilopascals (kPa)
- Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) >2.0
- CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices
- Patients with history of > grade 2 HE within 180 days of enrollment based on review of clinical documentation verifying the event. If a description of HE symptoms is provided in clinical documentation, but it is unclear if it meets Grade 2 criteria, the principal investigator will assess the clinical documentation and provide an HE grade.
Exclusion Criteria
- Non-English speaking
- Model for End-Stage Liver Disease (MELD) Score > 20
- Pregnancy (self-reported)
- Unable or unwilling to provide consent
- History of liver transplant
- Current or planned admission to a nursing facility
- Serum creatinine > 2.0 milligrams per deciliter (mg/dL) (with the exception that we will include patients with a serum creatinine > 2.0 mg/dL if they are receiving hemodialysis)
- Disorientation at the time of enrollment
- Barcelona-Clinic Liver Cancer (BCLC) Stage D Hepatocellular Carcinoma with Child-Turcotte-Pugh (CTP) Class C
- History of eating disorder
Data sourced from ClinicalTrials.gov (NCT04675775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.