Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30AG024824 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 27 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews | 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. | up to 11 weeks post enrollment |
| Change is EncephalApp - Stroop Score |
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
17 participants total were enrolled. Of those 17, 5 withdrew from the trial before receiving the medically-tailored meals (MTM), and 2 more withdrew during the trial. The data from the 7 participants who withdrew was not used in the results. The baseline data presented below is only for the participants who completed the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | up to 27 weeks post enrollment |
|
up to 27 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of cirrhosis | Hepatobiliary disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elliot Tapper | University of Michigan | 734-647-9252 | etapper@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2021 | Feb 2, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2021 | Feb 2, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D001201 | Ascites |
| D008107 | Liver Diseases |
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
| D009133 | Muscular Atrophy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. |
| 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. | 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. | Up to 90 minutes |
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. |
| baseline, up to 13 weeks |
| Change in One Minute Animal Naming Test (ANT) | The participants listed as many unique animals as possible in 60 seconds. | baseline, up to 27 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | up to 11 weeks post enrollment |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 27 weeks post enrollment |
|
|
|
| Secondary | 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. | 30 individuals who were screened were determined to meet the eligibility criteria for this trial. Of those 30, 10 declined to participate and 3 did not participate for other reasons. | Posted | Count of Participants | Participants | approximately 1 year (enrollment period) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 27 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes | Up to 90 minutes |
|
|
|
| Other Pre-specified | The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews | 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. | Not Posted | up to 11 weeks post enrollment | Participants |
| Other Pre-specified | Change is EncephalApp - Stroop Score | 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. | Not Posted | baseline, up to 13 weeks | Participants |
| Other Pre-specified | Change in One Minute Animal Naming Test (ANT) | The participants listed as many unique animals as possible in 60 seconds. | Not Posted | baseline, up to 27 weeks | Participants |
| 2 |
| 17 |
| 5 |
| 17 |
| 0 |
| 17 |
Not provided
Not provided
Not provided
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |