What this study is
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.
What's being tested
- HEAL-ME digital app
Intervention · BEHAVIORAL
HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
- Creatine supplementation
Intervention · DIETARY SUPPLEMENT
Patients will take 5g creatine supplementation daily for 13 weeks
- Whey protein supplementation
Intervention · DIETARY SUPPLEMENT
Patients will take 35g whey protein supplementation daily
- Placebo
Intervention · DIETARY SUPPLEMENT
Patients will be administered daily placebo supplementation.
Study details
- Official title
- Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis
- Sponsor
- University of California, San Francisco
- Conditions
- Cirrhosis · Frailty · Sarcopenia
- Enrolling
- 100 people
- Starts
- 2026-04-15
- Est. completion
- 2026-12
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California San Francisco
San Francisco, California, United States
- Melinda Wang, MD, MHS · Contact415-476-2777melinda.wang3@ucsf.edu
- Jennifer Lai, MD, MBA · Principal investigator
- Melinda Wang, MD, MHS · Sub-investigator
Recruiting
Study team
Sponsor
University of California, San Francisco
Study ID 25-44010
Principal investigator
Jennifer Lai, MD, MBA
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.