The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Sarcopenia Clinical Trial

Official title:

Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04675775
• Other study ID #: HUM00168821
• Secondary ID: P30AG024824
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: March 5, 2023

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 5, 2023
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cirrhosis will be based upon:

1. liver biopsy, OR

2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR

3. 2 of the following 4 criteria:

1. Ultrasound, Computed tomography (CT), or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)

2. Fibroscan liver stiffness score >13 kilopascals (kPa)

3. Laboratory testing: aspartate aminotransferase/platelet ratio index (APRI) >2.0

4. 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

Related Conditions & MeSH terms

• Ascites
• Brain Diseases
• Cirrhosis
• Frailty
• Hepatic Encephalopathy
• Liver Diseases
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews	The proportion of participants who complete all 24-hour Diet Recall interviews compared to the number of participants who did not complete all 24-Hour Diet Recall interviews.	up to 11 weeks post enrollment
Other	Change is EncephalApp - Stroop Score	This was a computerized, timed test of attention conducted on an Interactive Personal Application Device (iPad) or smart device by a phone application that asked participants to identify the color of words. The score was the sum of the time it took to complete color-word concordance and color-word discordance. A score of less than 190 was considered 'normal' cognitive function. Participants who were color-blind were excluded from performing this test.	baseline, up to 13 weeks
Other	Change in One Minute Animal Naming Test (ANT)	The participants listed as many unique animals as possible in 60 seconds.	baseline, up to 27 weeks
Primary	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	up to 27 weeks post enrollment
Primary	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	up to 11 weeks post enrollment
Secondary	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.	up to 27 weeks post enrollment
Secondary	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.	approximately 1 year (enrollment period)
Secondary	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.	up to 27 weeks
Secondary	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.	Up to 90 minutes