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Completed

NCT Number: NCT04675775

The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.

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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Key information

Conditions

Cirrhosis Ascites Atrophy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Frailty Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits

    Time frame: up to 27 weeks post enrollment

    Overall participant retention rate based on proportion of participants who completed all study visits

  2. Participant Adherence Rate to Medically-Tailored Meals (MTM)

    Time frame: 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 outcomes

  1. Proportion of Participants Who Completed All Study Assessments and Procedures

    Time frame: 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.

  2. Eligible Candidates Who Enrolled After Screening

    Time frame: 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.

  3. The Percentage of Enrolled Participants Who Dropped Out of Study

    Time frame: 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.

  4. Time Required to Complete Assessments

    Time frame: Up to 90 minutes

    Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.

Other outcomes

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

    Time frame: up to 11 weeks post enrollment

    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.

  2. Change is EncephalApp - Stroop Score

    Time frame: baseline, up to 13 weeks

    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.

  3. Change in One Minute Animal Naming Test (ANT)

    Time frame: baseline, up to 27 weeks

    The participants listed as many unique animals as possible in 60 seconds.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 19, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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