Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HEAL-ME digital app, Creatine supplementation, Whey protein supplementation, Placebo.
- Who it may be relevant to
- Registry conditions: Cirrhosis, Frailty, Sarcopenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis
Overview
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.
Interventions
- Behavioral HEAL-ME digital app
HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation - Dietary supplement Creatine supplementation
Patients will take 5g creatine supplementation daily for 13 weeks - Dietary supplement Whey protein supplementation
Patients will take 35g whey protein supplementation daily - Dietary supplement Placebo
Patients will be administered daily placebo supplementation.
Primary outcome measures
- Frailty [Time frame: From enrollment to end of study at 12 weeks]
Secondary outcome measures (6)
- Feasibility: Completion Rate [Time frame: From study enrollment to end of study at 12 weeks]
- Health-related quality of life (HRQOL) [Time frame: From enrollment to end of study at 12 weeks]
- Self-Reported Physical Activity [Time frame: From enrollment to end of study at 12 weeks]
- Sarcopenia [Time frame: From enrollment to end of study at 12 weeks]
- Feasibility: Adherence Rate [Time frame: From study enrollment to end of study at 12 weeks]
- Feasibility: Patient Satisfaction [Time frame: From study enrollment to end of study at 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of California San Francisco — San Francisco
Identifiers
NCT: NCT07029243 · 25-44010