Cirrhosis, Frailty, Sarcopenia
Conditions
Keywords
cirrhosis, liver, muscle, creatine, whey protein, frailty
Brief summary
Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition/exercise prehabilitation app will maintain muscle health in patients with liver disease.
Interventions
DIETARY_SUPPLEMENTWhey protein supplementation
Patients will take 35g whey protein supplementation daily
BEHAVIORALHEAL-ME digital app
HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
DIETARY_SUPPLEMENTCreatine supplementation
Patients will take 5g creatine supplementation daily for 13 weeks
DIETARY_SUPPLEMENTPlacebo
Patients will be administered daily placebo supplementation.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of cirrhosis by ICD-10 code, liver biopsy, abdominal imaging, or transient elastography * Access to digital device and internet at home * Ability to provide written informed consent before any study-related activities * Ability to remain in study for at least 3 months
Exclusion criteria
* Allergy to milk protein * On hemodialysis * No English language proficiency * Presence of condition or abnormality that in opinion of the Investigator will compromise safety of the patient or quality of the data * Concomitant severe underlying systemic illness that in the opinion of the Investigator would interfere with completion of study * Pregnant, breastfeeding, or intention of becoming pregnant during study time frame
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty | From enrollment to end of study at 12 weeks | Frailty will be used to assess muscle quality. The liver frailty index (LFI) includes the measurement of grip strength, chair stands, and balance. The Liver Fraity Index typically ranges from 1.0 to 5.0 with the following cut-offs: Robust is Liver Frailty Index \<3.2, Pre-frail is Liver Frailty Index between 3.2 and 4.4, and Frail is Liver frailty Index ≥4.4. We will use the previously identified cut-off of ≥4.4 (frail) vs. \<4.4 (not frail) to identify frailty in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Completion Rate | From study enrollment to end of study at 12 weeks | Completion rate will be assessed by study coordinators. Study coordinators will identify patients who do or do not complete the study during check-ins. Reasons for dropping out of the study will be recorded by study coordinators. |
| Health-related quality of life (HRQOL) | From enrollment to end of study at 12 weeks | The Patient Reported Outcomes Measurement Information System (PROMIS)-29 v 2.0 is a NIH-supported effort to develop and disseminate patient-reported measures of HRQOL that has built-in normative reference to the US general population. The PROMIS-29 v2.0 will be used to assess HRQOL. A score ≤25 has been used to define the 25th percentile value for the general population and has previously been used in our studies to be considered poor HRQOL. |
| Self-Reported Physical Activity | From enrollment to end of study at 12 weeks | The Duke Activity Status Index (DASI) will be used to measure self-reported physical activity. The DASI questionnaire provides a score from 0 to 58.2 with higher scores indicating better functional status and lower score indicating worse functional status. DASI will be measured as a continuous variable |
| Sarcopenia | From enrollment to end of study at 12 weeks | Sarcopenia will be measured by abdominal computed tomography (CT) scan measured CT-quantified skeletal muscle index (skeletal muscle index (SMI) \<50 cm2/m2 for men and \<39 cm2/m2 for women). We have previously demonstrated that CT-quantified sarcopenia is associated with worse outcomes in patients with cirrhosis. |
| Feasibility: Adherence Rate | From study enrollment to end of study at 12 weeks | Adherence rate will be assessed by study coordinators at each check-in. Adherence rate will include total adherence to the study protocol, adherence to supplement/placebo, and adherence to HEAL-ME activities. |
| Feasibility: Patient Satisfaction | From study enrollment to end of study at 12 weeks | Patient satisfaction will be assessed by study coordinators at the end of the study. Patient satisfaction will be reported as a scalar variable from 0 to 5. |
Countries
United States
Contacts
CONTACTMelinda Wang, MD, MHS
PRINCIPAL_INVESTIGATORJennifer Lai, MD, MBA
University of California, San Francisco
Outcome results
None listed