CirrhosisNCT07029243
Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis
A study testing HEAL-ME digital app, Creatine supplementation and Whey protein supplementation in people with Cirrhosis and Frailty, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Frailty, Sarcopenia
- What is being tested?
- HEAL-ME digital app, Creatine supplementation and Whey protein supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Melinda Wang, MD, MHS, 415-476-2777, melinda.wang3@ucsf.edu
Jennifer Lai, MD, MBA
About this study
Official title: Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis
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
- Being tested
- HEAL-ME digital app, Creatine supplementation, Whey protein supplementation, Placebo
- Keywords
- cirrhosis, liver, muscle, creatine, whey protein, frailty
- Medical subject headings
- Fibrosis, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEAL-ME digital appBehavioural
Also called exercise, nutrition
HEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation
Creatine supplementationDietary supplement
Also called Creatine
Patients will take 5g creatine supplementation daily for 13 weeks
Whey protein supplementationDietary supplement
Also called Whey
Patients will take 35g whey protein supplementation daily
PlaceboDietary supplement
Patients will be administered daily placebo supplementation.
| Study group | Role | What they receive |
|---|---|---|
| HEAL-ME and placebo supplementation | Placebo comparator | Patients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily Receives: 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 Receives: Behavioral: HEAL-ME digital app; Dietary Supplement: Creatine supplementation; Dietary Supplement: Whey protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of study at 12 weeks
Secondary outcomes (6)
Feasibility: Completion Rate
Completion rate will be assessed by study coordinators. Study coordinators will identify patients who do or do not complete the study during check-ins. Reasons for dropping out of the study will be recorded by study coordinators.
Measured: From study enrollment to end of study at 12 weeks
Health-related quality of life (HRQOL)
The Patient Reported Outcomes Measurement Information System (PROMIS)-29 v 2.0 is a NIH-supported effort to develop and disseminate patient-reported measures of HRQOL that has built-in normative reference to the US general population. The PROMIS-29 v2.0 will be used to assess HRQOL. A score ≤25 has been used to define the 25th percentile value for the general population and has previously been used in our studies to be considered poor HRQOL.
Measured: From enrollment to end of study at 12 weeks
Self-Reported Physical Activity
The Duke Activity Status Index (DASI) will be used to measure self-reported physical activity. The DASI questionnaire provides a score from 0 to 58.2 with higher scores indicating better functional status and lower score indicating worse functional status. DASI will be measured as a continuous variable
Measured: From enrollment to end of study at 12 weeks
Sarcopenia
Sarcopenia will be measured by abdominal computed tomography (CT) scan measured CT-quantified skeletal muscle index (skeletal muscle index (SMI) <50 cm2/m2 for men and <39 cm2/m2 for women). We have previously demonstrated that CT-quantified sarcopenia is associated with worse outcomes in patients with cirrhosis.
Measured: From enrollment to end of study at 12 weeks
Feasibility: Adherence Rate
Adherence rate will be assessed by study coordinators at each check-in. Adherence rate will include total adherence to the study protocol, adherence to supplement/placebo, and adherence to HEAL-ME activities.
Measured: From study enrollment to end of study at 12 weeks
Feasibility: Patient Satisfaction
Patient satisfaction will be assessed by study coordinators at the end of the study. Patient satisfaction will be reported as a scalar variable from 0 to 5.
Measured: From study enrollment to end of study at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start15 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Lai, MD, MBA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029243
- Sponsor's protocol ID
- 25-44010
- Status last verified
- Jul 2026
- First submitted
- 15 May 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang M, Kent D, Pariani K, Elia J, Seetharaman S, Lee C, Mansour J, Mak C, Tandon P, Lai J. Strength training intervention with creatine/whey protein supplementation vs placebo on frailty in older adults with cirrhosis (STRIVE): A Randomized Controlled Trial. Res Sq [Preprint]. 2026 Sep 19:rs.3.rs-10695023. doi: 10.21203/rs.3.rs-10695023/v1.
PubMed 42780265
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Prehabilitation With and Without Creatine/Whey Protein Supplementation Effects on Frailty In Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT07029243
- Acronym / sponsor ID
- 25-44010
- Conditions
- Cirrhosis, Frailty, Sarcopenia
- Keywords
- cirrhosis, liver, muscle, creatine, whey protein, frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEAL-ME and placebo supplementation | Placebo comparator | Behavioral: HEAL-ME digital app, Dietary Supplement: PlaceboPatients within this arm will be administered the HEAL-ME digital app and placebo supplementation daily |
| HEAL-ME and creatine/whey protein supplementation | Experimental | Behavioral: HEAL-ME digital app, Dietary Supplement: Creatine supplementation, Dietary Supplement: Whey protein supplementationPatients within this arm will be administered the HEAL-ME digital app and whey protein/creatine combination supplementation daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEAL-ME digital appAlso: exercise, nutritionHEAL-ME is a digital prehabilitation app that provides semi-guided nutrition/exercise prehabilitation | Behavioural | HEAL-ME and creatine/whey protein supplementation, HEAL-ME and placebo supplementation |
| Creatine supplementationAlso: CreatinePatients will take 5g creatine supplementation daily for 13 weeks | Dietary supplement | HEAL-ME and creatine/whey protein supplementation |
| Whey protein supplementationAlso: WheyPatients will take 35g whey protein supplementation daily | Dietary supplement | HEAL-ME and creatine/whey protein supplementation |
| PlaceboPatients will be administered daily placebo supplementation. | Dietary supplement | HEAL-ME and placebo supplementation |
Primary outcome
Frailty
Time frame: From enrollment to end of study at 12 weeks
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42780265Wang M, Kent D, Pariani K, Elia J, Seetharaman S, Lee C, Mansour J, Mak C, Tandon P, Lai J. Strength training intervention with creatine/whey protein supplementation vs placebo on frailty in older adults with cirrhosis (STRIVE): A Randomized Controlled Trial. Res Sq [Preprint]. 2026 Sep 19:rs.3.rs-10695023. doi: 10.21203/rs.3.rs-10695023/v1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Lai, MD, MBA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEAL-ME digital app, Creatine supplementation and Whey protein supplementation in people with Cirrhosis and Frailty, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melinda Wang, MD, MHS (415-476-2777, melinda.wang3@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: From enrollment to end of study at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07029243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.