The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2023-03-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis Ascites Liver Diseases Frailty Sarcopenia Hepatic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medically-tailored meals

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).

Group Type EXPERIMENTAL

Medically-tailored meals (MTM)

Intervention Type OTHER

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.

Protein supplements

Intervention Type DIETARY_SUPPLEMENT

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.

Nutrition education handout

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No