Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)BEAN-MASLDNCT07730853
Isocaloric Navy-Bean Substitution in Adults With MASLD
A study testing Dietary Supplement/Behavioral: Navy Bean-Rich Diet in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Liver Fibrosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- What is being tested?
- Dietary Supplement/Behavioral: Navy Bean-Rich Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-75 years of age with capacity to provide informed consent
- Clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior liver biopsy.
- Intermediate-stage fibrosis (F2-F3) confirmed by one of the following (most recent qualifying result): VCTE (FibroScan) 8.0-14 kPa, MRE 3.0-4.6 kPa (2D EPI @ 60 Hz), or liver biopsy read as F2-F3
- Body mass index 25-45 kg/m²
- Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management
- Alcohol intake below MASLD thresholds (≤15 drinks/week for men, ≤10 drinks/week for women)
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- Willing and able to consume study navy beans and complete dietary recalls (ASA-24/DSQ)
- Able to undergo MRI and MRE (no contraindications) and attend study visits
- Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes
Who cannot join
- Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)
- Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B/C cirrhosis, or clinical portal hypertension/decompensation
- Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months
- Legume/bean allergy or intolerance
- Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial
- Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks
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- Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)
- New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre/probiotics)
- Antibiotics, probiotics, or colonoscopy preparation within 8 weeks
- Planned bariatric surgery or other major weight-loss intervention during the study
- Recent weight change >5% within 8-12 weeks prior to baseline
- Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance
- Uncontrolled diabetes (HbA1c >10%), severe renal dysfunction (eGFR <45), or unstable cardiovascular, thyroid, or psychiatric illness
- Pregnant or breastfeeding
- Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)
- Participation in another interventional study within the last 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meena Bansal contact
United States1 site
Mount Sinai Hospital
New York, New York, 10029
Xiaotao Zhang, MD, PhD, 212-659-5555 ext. 85555, Xiaotao.Zhang@mountsinai.org
Siyang Shen, BS, Siyang.Shen@mountsinai.org
About this study
Official title: Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.
Read the detailed description
Rationale: Diet acts on MASLD progression through the gut-liver axis, in which microbial composition, intestinal barrier integrity, and microbe-derived metabolites influence hepatic inflammation, steatosis, and fibrosis. Navy beans supply fermentable fiber, resistant starch, and polyphenols that nourish short-chain-fatty-acid-producing microbes, and prior human work (the BE GONE trial) demonstrated increased microbial diversity, enrichment of beneficial taxa, and favorable metabolomic and proteomic shifts following an 8-week navy-bean intervention. An isocaloric substitution approach isolates bean-specific biologic effects from weight change, addressing a major confounder in MASLD dietary trials.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Being tested
- Dietary Supplement/Behavioral: Navy Bean-Rich Diet, Habitual Diet (Control)
- Keywords
- Navy beans, Dietary intervention, Isocaloric substitution, Gut microbiome, Gut-liver axis, Liver stiffness
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement/Behavioral: Navy Bean-Rich DietOther
Also called Navy Bean-Rich Diet
Isocaloric substitution in which navy beans replace an equivalent caloric load of the habitual diet under individualized registered-dietitian counseling, with resting-metabolic-rate-based prescription and a gradual dose ramp-up (½ to 1 cup). Total energy intake is maintained.
Habitual Diet (Control)Other
Participants maintain their usual diet without the navy-bean substitution during the assigned control period
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Habitual Diet → Navy Bean-Rich Diet | Experimental | Participants follow their habitual diet during Period 1 (12 weeks), then cross over to the isocaloric navy-bean-rich diet during Period 2 (12 weeks). Receives: Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet; Other: Habitual Diet (Control) |
| Sequence B: Navy Bean-Rich Diet → Habitual Diet | Experimental | Participants follow the isocaloric navy-bean-rich diet during Period 1 (12 weeks), then cross over to their habitual diet during Period 2 (12 weeks). Receives: Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet; Other: Habitual Diet (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility composite score
Feasibility is assessed as a composite of three pre-specified measure
- Recruitment velocity: number of participants randomized per month, calculated as total randomized divided by months of active enrollment.
- Retention at Week 24: proportion of randomized participants completing both 12-week crossover periods and the Week-24 visit within the protocol window, calculated as number retained divided by number randomized.
- Adherence with biomarker concordance: proportion of participants achieving ≥75% of prescribed navy-bean servings during the navy-bean phase with plasma pipecolic-acid concordance, calculated as number adherent-and-concordant divided by number evaluable.
Each component is scored 0 (below threshold), 1 (intermediate), or 2 (meets target) against pre-specified progression criteria, and the three are summed. The composite score ranges from 0 to 6, with higher scores indicating greater feasibility.
Measured: Week 24
Secondary outcomes (5)
Proportion of participants rating the navy-bean intervention as acceptable
Proportion of participants rating the navy-bean intervention as acceptable, defined as a score ≥4 on a 5-point Likert scale (minimum 1 = least acceptable, maximum 5 = most acceptable; higher scores indicate greater acceptability) assessing taste, tolerability, and convenience.
Measured: At Week 12 and Week 24
Proportion of visits with Isocaloric fidelity
Proportion of visits at which energy intake is within ±5% of the prescribed target with body-weight change ≤2% per period, calculated from dietary recalls and serial weights. Higher values indicate better maintenance of isocaloric substitution.
Measured: through Week 24
Change in hepatic fat by MRI-PDFF
Within-person difference in hepatic fat, measured as MRI proton density fat fraction (percent) from blinded central reads, comparing the navy-bean condition to the habitual condition. Lower MRI-PDFF indicates less hepatic steatosis.
Measured: Baseline (Week 0), Week 12, and Week 24
Change in alanine aminotransferase (ALT)
Serum ALT (U/L) levels. Lower ALT indicates less hepatocellular injury.
Measured: Baseline (Week 0), Week 12, and Week 24
Change in liver stiffness by MRE
Liver stiffness (kPa) by magnetic resonance elastography. Lower stiffness indicates less fibrosis burden.
Measured: Baseline (Week 0), Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotao Zhang, MD, PhD, Icahn School of Medicine at Mount Sinai
- Investigators
- Xiaotao Zhang, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730853
- Sponsor's protocol ID
- GCO 25-1954
- Acronym
- BEAN-MASLD
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
PubMed 38040541Zhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.
PubMed 31852462Baxter BA, Oppel RC, Ryan EP. Navy Beans Impact the Stool Metabolome and Metabolic Pathways for Colon Health in Cancer Survivors. Nutrients. 2018 Dec 22;11(1):28. doi: 10.3390/nu11010028.
PubMed 30583518Bajaj JS, Reddy KR, Tandon P, Lai JC, O'Leary JG, Wong F, Garcia-Tsao G, Vargas HE, Kamath PS, Biggins SW, Vutien P, Shaw J, Limon Miro AT, Bera C, McGinley JP, Sikaroodi M, Bush BJ, Thacker LR, Gillevet PM. Salivary microbiome and serum metabolomics add to clinical biomarkers to predict 6-month hospitalizations in a multicenter cirrhosis outpatient cohort. Hepatology. 2026 Jun 1;83(6):1483-1494. doi: 10.1097/HEP.0000000000001462. Epub 2025 Jul 9.
PubMed 40632657
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
- ClinicalTrials.gov ID
- NCT07730853
- Acronym / sponsor ID
- BEAN-MASLD / GCO 25-1954
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis, Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Keywords
- Navy beans, Dietary intervention, Isocaloric substitution, Gut microbiome, Gut-liver axis, Liver stiffness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 28 Jul 2026 (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.
This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.
Detailed description
Rationale: Diet acts on MASLD progression through the gut-liver axis, in which microbial composition, intestinal barrier integrity, and microbe-derived metabolites influence hepatic inflammation, steatosis, and fibrosis. Navy beans supply fermentable fiber, resistant starch, and polyphenols that nourish short-chain-fatty-acid-producing microbes, and prior human work (the BE GONE trial) demonstrated increased microbial diversity, enrichment of beneficial taxa, and favorable metabolomic and proteomic shifts following an 8-week navy-bean intervention. An isocaloric substitution approach isolates bean-specific biologic effects from weight change, addressing a major confounder in MASLD dietary trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Habitual Diet → Navy Bean-Rich Diet | Experimental | Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet, Other: Habitual Diet (Control)Participants follow their habitual diet during Period 1 (12 weeks), then cross over to the isocaloric navy-bean-rich diet during Period 2 (12 weeks). |
| Sequence B: Navy Bean-Rich Diet → Habitual Diet | Experimental | Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet, Other: Habitual Diet (Control)Participants follow the isocaloric navy-bean-rich diet during Period 1 (12 weeks), then cross over to their habitual diet during Period 2 (12 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults 18-75 years of age with capacity to provide informed consent
- Clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior liver biopsy.
- Intermediate-stage fibrosis (F2-F3) confirmed by one of the following (most recent qualifying result): VCTE (FibroScan) 8.0-14 kPa, MRE 3.0-4.6 kPa (2D EPI @ 60 Hz), or liver biopsy read as F2-F3
- Body mass index 25-45 kg/m²
- Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management
Key exclusion criteria (16 listed)
- Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)
- Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B/C cirrhosis, or clinical portal hypertension/decompensation
- Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months
- Legume/bean allergy or intolerance
- Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial
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 |
|---|---|---|
| Dietary Supplement/Behavioral: Navy Bean-Rich DietAlso: Navy Bean-Rich DietIsocaloric substitution in which navy beans replace an equivalent caloric load of the habitual diet under individualized registered-dietitian counseling, with resting-metabolic-rate-based prescription and a gradual dose ramp-up (½ to 1 cup). Total energy intake is maintained. | Other | Sequence A: Habitual Diet → Navy Bean-Rich Diet, Sequence B: Navy Bean-Rich Diet → Habitual Diet |
| Habitual Diet (Control)Participants maintain their usual diet without the navy-bean substitution during the assigned control period | Other | Sequence A: Habitual Diet → Navy Bean-Rich Diet, Sequence B: Navy Bean-Rich Diet → Habitual Diet |
Primary outcome
Feasibility composite score
Time frame: Week 24
Feasibility is assessed as a composite of three pre-specified measure 1. Recruitment velocity: number of participants randomized per month, calculated as total randomized divided by months of active enrollment. 2. Retention at Week 24: proportion of randomized participants completing both 12-week crossover periods and the Week-24 visit within the protocol window, calculated as number retained divided by number randomized. 3. Adherence with biomarker concordance: proportion of participants achieving ≥75% of prescribed navy-bean servings during the navy-bean phase with plasma pipecolic-acid concordance, calculated as number adherent-and-concordant divided by number evaluable. Each component is scored 0 (below threshold), 1 (intermediate), or 2 (meets target) against pre-specified progression criteria, and the three are summed. The composite score ranges from 0 to 6, with higher scores indicating greater feasibility.
5 secondary outcomes
Proportion of participants rating the navy-bean intervention as acceptable
Time frame: At Week 12 and Week 24
Proportion of visits with Isocaloric fidelity
Time frame: through Week 24
Change in hepatic fat by MRI-PDFF
Time frame: Baseline (Week 0), Week 12, and Week 24
Change in alanine aminotransferase (ALT)
Time frame: Baseline (Week 0), Week 12, and Week 24
Change in liver stiffness by MRE
Time frame: Baseline (Week 0), Week 12, and Week 24
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 12 Aug 2026.
- Background: PubMed 38040541Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.
- Background: PubMed 31852462Zhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.
- Background: PubMed 30583518Baxter BA, Oppel RC, Ryan EP. Navy Beans Impact the Stool Metabolome and Metabolic Pathways for Colon Health in Cancer Survivors. Nutrients. 2018 Dec 22;11(1):28. doi: 10.3390/nu11010028.
- Background: PubMed 40632657Bajaj JS, Reddy KR, Tandon P, Lai JC, O'Leary JG, Wong F, Garcia-Tsao G, Vargas HE, Kamath PS, Biggins SW, Vutien P, Shaw J, Limon Miro AT, Bera C, McGinley JP, Sikaroodi M, Bush BJ, Thacker LR, Gillevet PM. Salivary microbiome and serum metabolomics add to clinical biomarkers to predict 6-month hospitalizations in a multicenter cirrhosis outpatient cohort. Hepatology. 2026 Jun 1;83(6):1483-1494. doi: 10.1097/HEP.0000000000001462. Epub 2025 Jul 9.
- Funding announcement: NIH PAS-25-102Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Meena Bansal contact
Xiaotao Zhang, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement/Behavioral: Navy Bean-Rich Diet in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Liver Fibrosis, run by Icahn School of Medicine at Mount Sinai 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 9 inclusion and 16 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: opening soon, as of the sponsor's last update on 12 Aug 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. 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 Xiaotao Zhang, MD, PhD (212-659-5555, Xiaotao.Zhang@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility composite score (time frame: Week 24). 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 NCT07730853, which also lists 4 linked publications.
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 12 Aug 2026.