Ascites, Cirrhosis, Frailty, Hepatic Encephalopathy, Liver Diseases, Sarcopenia
Conditions
Keywords
Nutrition
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.
Interventions
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.
DIETARY_SUPPLEMENTProtein 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.
BEHAVIORALNutrition 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.
Sponsors
National Institute on Aging (NIA)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Eligible Candidates Who Enrolled After Screening | 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. |
| Proportion of Participants Who Completed All Study Assessments and Procedures | 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. |
| The Percentage of Enrolled Participants Who Dropped Out of Study | 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. |
| Time Required to Complete Assessments | 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
| Measure | Time frame | Description |
|---|---|---|
| Change is EncephalApp - Stroop Score | 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. |
| The Proportion of Participants Who Complete All 24-hour Diet Recall Interviews | 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. |
| Change in One Minute Animal Naming Test (ANT) | baseline, up to 27 weeks | The participants listed as many unique animals as possible in 60 seconds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Medically-tailored Meals |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 12.8 |
| Race/Ethnicity, Customized Non-white | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 5 / 17 |
Outcome results
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
Time frame: up to 27 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medically-tailored Meals | Overall Participant Retention Rate Based on Proportion of Participants Who Complete All Study Visits | 10 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
Time frame: up to 11 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medically-tailored Meals | Participant Adherence Rate to Medically-Tailored Meals (MTM) | 10 Participants |
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.
Time frame: approximately 1 year (enrollment period)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medically-tailored Meals | Eligible Candidates Who Enrolled After Screening | 17 Participants |
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.
Time frame: up to 27 weeks post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medically-tailored Meals | Proportion of Participants Who Completed All Study Assessments and Procedures | 8 Participants |
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.
Time frame: up to 27 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Medically-tailored Meals | The Percentage of Enrolled Participants Who Dropped Out of Study | 7 Participants |
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.
Time frame: Up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medically-tailored Meals | Time Required to Complete Assessments | 43.27 minutes | Standard Deviation 21.44 |
Other Pre-specified
Change in One Minute Animal Naming Test (ANT)
The participants listed as many unique animals as possible in 60 seconds.
Time frame: baseline, up to 27 weeks
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.
Time frame: baseline, up to 13 weeks
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.
Time frame: up to 11 weeks post enrollment