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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07029243
Status
Recruiting
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Conditions

  • Cirrhosis
  • Frailty
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 19, 2025
Start date
Apr 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Melinda Wang, MD, MHS
[email protected]
415-476-2777
Jennifer Lai, MD, MBA (PRINCIPAL_INVESTIGATOR)
Melinda Wang, MD, MHS (SUB_INVESTIGATOR)

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