Not Yet RecruitingNot Applicable

Isocaloric Navy-Bean Substitution in Adults With MASLD

United States40 participantsStarted 2026-09-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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 antic…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing whether swapping navy beans into your diet — without changing total calories — is practical for people with MASLD; since the primary goal is just measuring feasibility rather than proving the diet actually improves liver disease, what would we realistically learn about my condition from my participation?
2The trial isn't recruiting yet, so there could be a wait before I could even join — given how quickly liver fibrosis can progress, should I be pursuing established treatments now rather than waiting to see if I qualify for this study?
3Since this is a dietary substitution study rather than a drug trial and is listed as Phase NA, what does that mean for what's already known about the safety and liver health effects of a navy-bean-based diet in people with my stage of MASLD or MASH?
4The study focuses on MASLD, liver fibrosis, and MASH together — given my specific diagnosis and how advanced my condition is, do you think I'd be a realistic candidate for a feasibility-focused nutrition study, or would a more aggressive treatment approach make more sense for me right now?
5How would participating in a controlled dietary substitution study affect my ability to also pursue other treatments or make other lifestyle changes, and is there a standard-of-care option I should try first before considering a study like this?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility composite score

Timeframe: Week 24

Trial details

NCT IDNCT07730853

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-08-31

Contact for this trial

Xiaotao Zhang, MD, PhD

212-659-5555 Xiaotao.Zhang@mountsinai.org

View on ClinicalTrials.gov More Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) trials