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

NCT07029243 | Not Yet Recruiting DMC

• 1 other identifier: 25-44010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

cirrhosis; liver; muscle; creatine; whey protein; frailty

Outcome Measures

Primary Outcomes (1)

• Frailty

  Frailty will be used to assess muscle quality. The liver frailty index (LFI) includes the measurement of grip strength, chair stands, and balance. The Liver Fraity Index typically ranges from 1.0 to 5.0 with the following cut-offs: Robust is Liver Frailty Index \<3.2, Pre-frail is Liver Frailty Index between 3.2 and 4.4, and Frail is Liver frailty Index ≥4.4. We will use the previously identified cut-off of ≥4.4 (frail) vs. \<4.4 (not frail) to identify frailty in this study.

  From enrollment to end of study at 12 weeks

Secondary Outcomes (6)

• Feasibility: Completion Rate

  From study enrollment to end of study at 12 weeks

• Health-related quality of life (HRQOL)

  From enrollment to end of study at 12 weeks

• Self-Reported Physical Activity

  From enrollment to end of study at 12 weeks

• Sarcopenia

  From enrollment to end of study at 12 weeks

• Feasibility: Adherence Rate

  From study enrollment to end of study at 12 weeks

Study Arms (2)

HEAL-ME and placebo supplementation

PLACEBO COMPARATOR

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

Behavioral: HEAL-ME digital app; Dietary Supplement: Placebo

HEAL-ME and creatine/whey protein supplementation

EXPERIMENTAL

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

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

Interventions

HEAL-ME digital app BEHAVIORAL

HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation

Also known as: exercise, nutrition

HEAL-ME and creatine/whey protein supplementation; HEAL-ME and placebo supplementation

Creatine supplementation DIETARY_SUPPLEMENT

Patients will take 5g creatine supplementation daily for 13 weeks

Also known as: Creatine

HEAL-ME and creatine/whey protein supplementation

Whey protein supplementation DIETARY_SUPPLEMENT

Patients will take 35g whey protein supplementation daily

Also known as: Whey

HEAL-ME and creatine/whey protein supplementation

Placebo DIETARY_SUPPLEMENT

Patients will be administered daily placebo supplementation.

HEAL-ME and placebo supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Fibrosis; Frailty; Sarcopenia

Interventions

Exercise; Nutritional Status; Creatine; Whey

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Milk; Beverages; Dairy Products; Food; Food and Beverages

Study Officials

• Jennifer Lai, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Wang, MD, MHS

CONTACT

415-476-2777; melinda.wang3@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)