An interventional study of Dietary Supplement/Behavioral: Navy Bean-Rich Diet and Habitual Diet (Control) in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Liver Fibrosis and Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
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).
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).
Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet · Other: Habitual Diet (Control)
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.
Also known as: Navy Bean-Rich Diet
Participants maintain their usual diet without the navy-bean substitution during the assigned control period
Feasibility composite score
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.
Time frame: Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Week 12, and Week 24
Change in alanine aminotransferase (ALT)
Serum ALT (U/L) levels. Lower ALT indicates less hepatocellular injury.
Time frame: 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.
Time frame: Baseline (Week 0), Week 12, and Week 24
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Icahn School of Medicine at Mount Sinai