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

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

  • Cirrhosis
  • Frailty
  • Sarcopenia

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