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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04675775
Other study ID # HUM00168821
Secondary ID P30AG024824
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2021
Est. completion date March 5, 2023

Study information

Verified date February 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date March 5, 2023
Est. primary completion date November 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
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.
Dietary Supplement:
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.
Behavioral:
Nutrition 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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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. baseline, up to 13 weeks
Other 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
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 up to 27 weeks post enrollment
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 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. 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. 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. 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. Up to 90 minutes
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