CirrhosisNCT04675775
The BRAINFOOD Trial to Prevent Recurrent Hepatic Encephalopathy.
A study testing Medically-tailored meals (MTM), Protein supplements and Nutrition education handout in people with Cirrhosis and Ascites, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites, Liver Diseases
- What is being tested?
- Medically-tailored meals (MTM), Protein supplements and Nutrition education handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 5 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial
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
- Being tested
- Medically-tailored meals (MTM), Protein supplements, Nutrition education handout
- Keywords
- Nutrition
- Medical subject headings
- Fibrosis, Ascites, Liver Diseases, Frailty, Sarcopenia, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 supplementsDietary 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 handoutBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Medically-tailored meals (MTM); Dietary Supplement: Protein supplements; Behavioral: Nutrition education handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 11 weeks post enrollment
Secondary outcomes (4)
Proportion of Participants Who Completed All Study Assessments and Procedures
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.
Measured: up to 27 weeks post enrollment
Eligible Candidates Who Enrolled After Screening
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.
Measured: approximately 1 year (enrollment period)
The Percentage of Enrolled Participants Who Dropped Out of Study
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.
Measured: up to 27 weeks
Time Required to Complete Assessments
Feasibility of the assessments were evaluated by measuring the amount of time participants required to complete all assessments in minutes.
Measured: Up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start21 Jan 2021
- Primary completion2 Nov 2022
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675775
- Sponsor's protocol ID
- HUM00168821
- Other IDs
- P30AG024824
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2020
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medically-Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial
- ClinicalTrials.gov ID
- NCT04675775
- Acronym / sponsor ID
- HUM00168821
- Conditions
- Cirrhosis, Ascites, Liver Diseases, Frailty, Sarcopenia, Hepatic Encephalopathy
- Keywords
- Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medically-tailored meals | Experimental | Other: Medically-tailored meals (MTM), Dietary Supplement: Protein supplements, Behavioral: Nutrition education handoutParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of cirrhosis will be based upon:
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Medically-tailored meals |
| Protein supplementsA 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. | Dietary supplement | Medically-tailored meals |
| Nutrition education handoutA 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. | Behavioural | Medically-tailored meals |
Primary outcome
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
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
4 secondary outcomes
Proportion of Participants Who Completed All Study Assessments and Procedures
Time frame: up to 27 weeks post enrollment
Eligible Candidates Who Enrolled After Screening
Time frame: approximately 1 year (enrollment period)
The Percentage of Enrolled Participants Who Dropped Out of Study
Time frame: up to 27 weeks
Time Required to Complete Assessments
Time frame: Up to 90 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Tapper, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically-tailored meals (MTM), Protein supplements and Nutrition education handout in people with Cirrhosis and Ascites, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits (time frame: up to 27 weeks post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.