Recruiting

HEAL-ME with Creatine & Whey Protein

Sponsor:

UCLA

Code:

NCT07029243

Conditions

Cirrhosis

Frailty

Sarcopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HEAL-ME digital app

Creatine supplementation

Whey protein supplementation

Placebo

Study Details

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.

Conditions

Cirrhosis

Frailty

Sarcopenia

Study ID

NCT07029243

Start date

Apr 15, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: HEAL-ME and placebo supplementation

Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily

experimental: HEAL-ME and creatine/whey protein supplementation

Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily

Interventions

HEAL-ME digital app

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

Creatine supplementation

Patients will take 5g creatine supplementation daily for 13 weeks

Whey protein supplementation

Patients will take 35g whey protein supplementation daily

Placebo

Patients will be administered daily placebo supplementation.

Primary outcome measure

  • Frailty [ Time Frame: From enrollment to end of study at 12 weeks ]

Central Contacts and Locations

Central contacts

Melinda Wang, MD, MHS

415-476-2777melinda.wang3@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Melinda Wang, MD, MHS

415-476-2777melinda.wang3@ucsf.edu

Principal Investigator:

Jennifer Lai, MD, MBA

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • cirrhosis
  • liver
  • muscle
  • creatine
  • whey protein
  • frailty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.