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The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Primary Purpose

Cirrhosis, Ascites, Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medically-tailored meals (MTM)
Protein supplements
Nutrition education handout
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medically-tailored meals

Arm Description

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 2000 grams a day).

Outcomes

Primary Outcome Measures

Overall subject retention rate based on proportion of subjects who complete all study visits
Overall subject retention rate based on proportion of subjects who complete all study visits
Subject adherence rate to Medically-Tailored Meals (MTM) based on proportion of subjects who consume ≥75% of delivered meals and evening snack
The subject adherence rate to Medically-Tailored Meals (MTM) based on proportion of subjects who consume ≥75% of delivered meals and evening snack

Secondary Outcome Measures

Proportion of subjects who complete all study assessments and procedures
The number of subjects who complete all study assessments and procedures compared to the number of subjects who do not complete all study assessments and procedures
Number of eligible candidates screened and percentage of those enrolled
The number of eligible candidates screened and the percentage of eligible candidates who enrolled in the study
The proportion of subjects who complete all 24-hour Diet Recall interviews
The number of subjects who complete all 24-hour Diet Recall interviews compared to the number of subjects who do not complete all 24-Hour Diet Recall interviews
Change in one minute Animal Naming Test (ANT)
The participants list as many unique animals as possible in 60 seconds.
Change is EncephalApp - Stroop score
This is a computerized, timed test of attention conducted on an Interactive Personal Application Device (iPad) or smart device by a phone application that asks patients to identify the color of words. The score is the sum of the time it takes to complete color-word concordance and color-word discordance. A score of less than 190 is considered 'normal' cognitive function. Subjects who are color-blind will be excluded from performing this test.
The percentage of enrolled subjects that drop out of study
The percentage of enrolled subjects who drop-out of either study stage before the final study visit due to withdrawal by subject or lost to follow-up, and not due to death, withdrawal by study staff or principal investigator discretion.

Full Information

First Posted
December 15, 2020
Last Updated
March 5, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04675775
Brief Title
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
Official Title
Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
March 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Ascites, Liver Diseases, Frailty, Sarcopenia, Hepatic Encephalopathy
Keywords
Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medically-tailored meals
Arm Type
Experimental
Arm Description
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 2000 grams a day).
Intervention Type
Other
Intervention Name(s)
Medically-tailored meals (MTM)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplements
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education handout
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall subject retention rate based on proportion of subjects who complete all study visits
Description
Overall subject retention rate based on proportion of subjects who complete all study visits
Time Frame
up to 27 weeks post enrollment
Title
Subject adherence rate to Medically-Tailored Meals (MTM) based on proportion of subjects who consume ≥75% of delivered meals and evening snack
Description
The subject adherence rate to Medically-Tailored Meals (MTM) based on proportion of subjects who consume ≥75% of delivered meals and evening snack
Time Frame
up to 11 weeks post enrollment
Secondary Outcome Measure Information:
Title
Proportion of subjects who complete all study assessments and procedures
Description
The number of subjects who complete all study assessments and procedures compared to the number of subjects who do not complete all study assessments and procedures
Time Frame
up to 27 weeks post enrollment
Title
Number of eligible candidates screened and percentage of those enrolled
Description
The number of eligible candidates screened and the percentage of eligible candidates who enrolled in the study
Time Frame
approximately 1 year (enrollment period)
Title
The proportion of subjects who complete all 24-hour Diet Recall interviews
Description
The number of subjects who complete all 24-hour Diet Recall interviews compared to the number of subjects who do not complete all 24-Hour Diet Recall interviews
Time Frame
up to 11 weeks post enrollment
Title
Change in one minute Animal Naming Test (ANT)
Description
The participants list as many unique animals as possible in 60 seconds.
Time Frame
baseline, up to 27 weeks
Title
Change is EncephalApp - Stroop score
Description
This is a computerized, timed test of attention conducted on an Interactive Personal Application Device (iPad) or smart device by a phone application that asks patients to identify the color of words. The score is the sum of the time it takes to complete color-word concordance and color-word discordance. A score of less than 190 is considered 'normal' cognitive function. Subjects who are color-blind will be excluded from performing this test.
Time Frame
baseline, up to 13 weeks
Title
The percentage of enrolled subjects that drop out of study
Description
The percentage of enrolled subjects who drop-out of either study stage before the final study visit due to withdrawal by subject or lost to follow-up, and not due to death, withdrawal by study staff or principal investigator discretion.
Time Frame
up to 27 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

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