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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
HEAL-ME and placebo supplementation 		Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily
  • Behavioral: HEAL-ME digital app
    HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
    Other names:
    • exercise
    • nutrition
  • Dietary Supplement: Placebo
    Patients will be administered daily placebo supplementation.
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
  • Behavioral: HEAL-ME digital app
    HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
    Other names:
    • exercise
    • nutrition
  • Dietary Supplement: Creatine supplementation
    Patients will take 5g creatine supplementation daily for 13 weeks
    Other names:
    • Creatine
  • Dietary Supplement: Whey protein supplementation
    Patients will take 35g whey protein supplementation daily
    Other names:
    • Whey

Recruiting Locations

University of California San Francisco
San Francisco, California 94143
Contact:
Melinda Wang, MD, MHS
415-476-2777
melinda.wang3@ucsf.edu

More Details

Status
Recruiting
Sponsor
University of California, San Francisco

Study Contact

Melinda Wang, MD, MHS
415-476-2777
melinda.wang3@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.