Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07029243

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cirrhosis Atrophy Fibrosis Frailty Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Jennifer Lai, MD, MBA

PRINCIPAL_INVESTIGATOR

Melinda Wang, MD, MHS

CONTACT

[email protected]

415-476-2777

Melinda Wang, MD, MHS

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEAL-ME digital app

Behavioral

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

Other names: exercise, nutrition

creatine supplementation

Dietary Supplement

Patients will take 5g creatine supplementation daily for 13 weeks

Other names: Creatine

Whey protein supplementation

Dietary Supplement

Patients will take 35g whey protein supplementation daily

Other names: Whey

Placebo

Dietary Supplement

Patients will be administered daily placebo supplementation.

Primary outcomes

  1. Frailty

    Time frame: 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 outcomes

  1. Feasibility: Completion Rate

    Time frame: 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.

  2. Health-related quality of life (HRQOL)

    Time frame: 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.

  3. Self-Reported Physical Activity

    Time frame: 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

  4. Sarcopenia

    Time frame: 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.

  5. Feasibility: Adherence Rate

    Time frame: 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.

  6. Feasibility: Patient Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melinda Wang, MD, MHS

CONTACT

[email protected]

415-476-2777

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.