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Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis

ConditionsCirrhosisFrailtySarcopenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEAL-ME digital app

    Behavioral

    HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation

  • Creatine supplementation

    Dietary supplement

    Patients will take 5g creatine supplementation daily for 13 weeks

  • Whey protein supplementation

    Dietary supplement

    Patients will take 35g whey protein supplementation daily

  • Placebo

    Dietary supplement

    Patients will be administered daily placebo supplementation.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HEAL-ME and placebo supplementationPlacebo comparator 2 interventions
Group B: HEAL-ME and creatine/whey protein supplementationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Frailty

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.

Time frame
From enrollment to end of study at 12 weeks

Secondary outcomes

1

Feasibility: Completion Rate

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.

Time frame
From study enrollment to end of study at 12 weeks
2

Health-related quality of life (HRQOL)

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.

Time frame
From enrollment to end of study at 12 weeks
3

Self-Reported Physical Activity

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

Time frame
From enrollment to end of study at 12 weeks
4

Sarcopenia

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.

Time frame
From enrollment to end of study at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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