The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Not Applicable

Completed

• Conditions: Cirrhosis; Ascites; Frailty; Sarcopenia; Liver Diseases; Hepatic Encephalopathy
• Interventions: Other: Medically-tailored meals (MTM); Dietary Supplement: Protein supplements; Behavioral: Nutrition education handout

• Registration Number: NCT04675775
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Study Start: 2021-01-21
• Primary Completion: 2022-11-02
• Study Completion: 2023-03-05
• Status Verified: 2024-02
• Results First Submitted: 2024-02-09
• Results First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Results First Posted: 2024-03-06
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medically-tailored meals	Protein supplements	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).
Medically-tailored meals	Medically-tailored meals (MTM)	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).
Medically-tailored meals	Nutrition education handout	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).

Primary Outcome Measures

Name	Time	Method
Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits	up to 27 weeks post enrollment	Overall participant retention rate based on proportion of participants who completed all study visits
Participant Adherence Rate to Medically-Tailored Meals (MTM)	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

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Who Completed All Study Assessments and Procedures	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.
Eligible Candidates Who Enrolled After Screening	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.
The Percentage of Enrolled Participants Who Dropped Out of Study	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.
Time Required to Complete Assessments	Up to 90 minutes	Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States