Whey Protein + Creatine for Liver Cirrhosis

Overseen By Melinda Wang, MD, MHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Allergy to milk, Hemodialysis, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a digital app called HEAL-ME, combined with whey protein and creatine supplements, can maintain muscle health in people with liver cirrhosis (a long-term liver disease). Participants will receive either the actual supplements or a placebo (a harmless pill resembling the real supplement) to compare results. The trial suits individuals with a confirmed diagnosis of cirrhosis who have access to a digital device and internet at home. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance muscle health for those with liver cirrhosis.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this digital prehabilitation app and supplementation are safe for patients with liver disease?

Research has shown that incorporating creatine into a regular diet does not increase health problems for individuals aged 12 and over. This finding reassures those considering its use. However, one report noted liver injury in a person who took whey protein and creatine together, indicating that while these supplements are generally safe, some individuals might experience side effects.

These supplements are widely used and generally well-tolerated. Prospective trial participants should stay informed and discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whey protein and creatine for liver cirrhosis because these supplements might offer a novel way to support liver health. Unlike traditional treatments that focus on managing symptoms or slowing disease progression through medication, whey protein and creatine aim to enhance muscle mass and improve overall metabolism, which can be particularly beneficial for cirrhosis patients who often suffer from muscle wasting. Moreover, this approach is non-invasive and could potentially be used alongside existing therapies to provide a more comprehensive care strategy. This combination also taps into the body's natural processes, offering a promising alternative to more conventional medication-based treatments.

What evidence suggests that this trial's treatments could be effective for maintaining muscle health in patients with liver disease?

Research has shown that creatine and whey protein might help maintain muscle health in people with liver disease. In this trial, one group of participants will receive a combination of creatine and whey protein supplementation alongside the HEAL-ME digital app. Studies suggest that creatine may lower the risk of liver problems, especially in older adults. Whey protein, commonly used by athletes, aids in building and repairing muscles. Together, these supplements could support muscle health in individuals with liver issues. However, a report has linked these supplements to liver injury, so their use requires monitoring. Overall, creatine and whey protein appear promising for improving muscle health in liver disease patients. ^{1 2 4 5 6}

Who Is on the Research Team?

Jennifer Lai, MD, MBA

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients with chronic liver disease who are experiencing frailty and muscle health issues, such as sarcopenia. Participants should be interested in using a digital prehabilitation app and taking supplements to maintain muscle health.

Inclusion Criteria

Access to digital device and internet at home

I have been diagnosed with cirrhosis.

Ability to provide written informed consent before any study-related activities

Exclusion Criteria

No English language proficiency

I am currently on hemodialysis.

Presence of condition or abnormality that in opinion of the Investigator will compromise safety of the patient or quality of the data

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the HEAL-ME digital app and receive either creatine/whey protein supplementation or placebo daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein and Creatine

Trial Overview The study tests the effectiveness of a digital app called HEAL-ME combined with creatine and whey protein supplementation on muscle health in liver disease patients. It aims to see if this approach helps maintain muscle mass and strength.

How Is the Trial Designed?

Group I: HEAL-ME and creatine/whey protein supplementation Experimental Treatment 3 Interventions

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

Group II: HEAL-ME and placebo supplementation Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07029243

Prehab and Creatine/Whey Supplementation in Frailty ... This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9922125/

Creatine consumption and liver disease manifestations in ... Our data extend recent population‐based findings, where additional creatine was associated with a lower risk of liver conditions in the elderly ...

3. withpower.com withpower.com/trial/phase-fibrosis-9-2025-cb714

Whey Protein + Creatine for Liver Cirrhosis This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07029243

Prehab and Creatine/Whey Supplementation in Frailty Among ... This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining ...

5. researchgate.net researchgate.net/publication/5400852_Cholestatic_Liver_Injury_Associated_with_Whey_Protein_and_Creatine_Supplements

Cholestatic Liver Injury Associated with Whey Protein and ... We present a case of acute cholestatic liver injury associated with the combination of whey protein and creatine supplements.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18452122/

Cholestatic liver injury associated with whey protein and ... We present a case of acute cholestatic liver injury associated with the combination of whey protein and creatine supplements.