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

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Cirrhosis; Frailty; Sarcopenia

Treatments: Behavioral: HEAL-ME digital app; Dietary Supplement: Creatine supplementation; Dietary Supplement: Whey protein supplementation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07029243

25-44010

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

HEAL-ME and placebo supplementation

Placebo Comparator group

Description:

Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily

Treatment:

Dietary Supplement: Placebo

Behavioral: HEAL-ME digital app

HEAL-ME and creatine/whey protein supplementation

Experimental group

Description:

Patients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily

Treatment:

Dietary Supplement: Whey protein supplementation

Dietary Supplement: Creatine supplementation

Behavioral: HEAL-ME digital app