The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

NCT04675775 | Completed Results

• 2 other identifiers: HUM00168821P30AG024824
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Ascites; Liver Diseases; Frailty; Sarcopenia; Hepatic Encephalopathy

Keywords

Nutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Proportion of Participants Who Completed All Study Assessments and Procedures

  up to 27 weeks post enrollment

• Eligible Candidates Who Enrolled After Screening

  approximately 1 year (enrollment period)

• The Percentage of Enrolled Participants Who Dropped Out of Study

  up to 27 weeks

• Time Required to Complete Assessments

  Up to 90 minutes

Other Outcomes (3)

• The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews

  up to 11 weeks post enrollment

• Change is EncephalApp - Stroop Score

  baseline, up to 13 weeks

• Change in One Minute Animal Naming Test (ANT)

  baseline, up to 27 weeks

Study Arms (1)

Medically-tailored meals

EXPERIMENTAL

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).

Other: Medically-tailored meals (MTM); Dietary Supplement: Protein supplements; Behavioral: Nutrition education handout

Interventions

Medically-tailored meals (MTM) 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.

Medically-tailored meals

Protein supplements 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.

Medically-tailored meals

Nutrition education handout 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.

Medically-tailored meals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of cirrhosis will be based upon:
• liver biopsy, OR
• history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Fibrosis; Ascites; Liver Diseases; Frailty; Sarcopenia; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Elliot Tapper
• Organization: University of Michigan

etapper@med.umich.edu

734-647-9252

Study Officials

• Elliot Tapper, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: January 21, 2021
• Primary Completion: November 2, 2022
• Study Completion: March 5, 2023
• Last Updated: March 6, 2024
• Results First Posted: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)