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

NCT ID: NCT07029243

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis Frailty Sarcopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HEAL-ME and placebo supplementation

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

Group Type PLACEBO_COMPARATOR

HEAL-ME digital app

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

Patients will be administered daily placebo supplementation.

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

Group Type EXPERIMENTAL

HEAL-ME digital app

Intervention Type BEHAVIORAL

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

Creatine supplementation

Intervention Type DIETARY_SUPPLEMENT

Patients will take 5g creatine supplementation daily for 13 weeks

Whey protein supplementation

Intervention Type DIETARY_SUPPLEMENT

Patients will take 35g whey protein supplementation daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HEAL-ME digital app

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

Intervention Type BEHAVIORAL

Creatine supplementation

Patients will take 5g creatine supplementation daily for 13 weeks

Intervention Type DIETARY_SUPPLEMENT

Whey protein supplementation

Patients will take 35g whey protein supplementation daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Patients will be administered daily placebo supplementation.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

exercise nutrition Creatine Whey

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jennifer Lai, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Melinda Wang, MD, MHS

Role: CONTACT

415-476-2777

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melinda Wang, MD, MHS

Role: primary

415-476-2777

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25-44010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition and Exercise for Sarcopenia
NCT00872911 COMPLETED PHASE1