Randomized Feasibility Trial of Isocaloric Navy Bean Substitution in Adults with MASLD
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PROJECT SUMMARY Metabolic dysfunction–associated steatotic liver disease (MASLD) is the most common chronic liver disease and a rising cause of cirrhosis, cancer, and transplantation. Safe, scalable options for people with established fibrosis remain limited. This randomized feasibility trial (Small R01 pilot) will enroll adults with MASLD and fibrosis stage F2–F3 (documented by magnetic resonance elastography [MRE], vibration-controlled transient elastography [VCTE], or recent biopsy) to test a pragmatic, isocaloric navy-bean substitution and to generate the feasibility and estimation data needed to power a definitive multi-site efficacy trial. We will conduct a single- site, 24-week, two-period, two-sequence randomized crossover study (N=40) recruiting from the Mount Sinai Steatotic Liver Disease Registry. The intervention replaces calories from habitual foods with navy beans to isolate weight-independent effects. Primary feasibility endpoints are recruitment, retention, and adherence; adherence is verified with a validated biochemical marker (plasma pipecolic acid). The primary pilot biological signal is hepatic fat by MRI-PDFF (proton-density fat fraction); liver stiffness by MRE and ALT are exploratory given the F2–F3 fibrosis context. A prespecified carryover check (Grizzle test) with a Period-1 parallel-group fallback preserves unbiased inference. Multi-omics profiling (oral/gut microbiome; plasma metabolomics/proteomics) will identify pathway- level signatures linked to MRI-PDFF and nominate biomarkers for enrichment in the next-stage trial. Patient- reported outcomes (PROs) and brief interviews will inform acceptability, tolerability, preferred food forms, and an implementation toolkit for real-world use across diverse populations. Specific Aims: (1) Feasibility & pilot signals—estimate recruitment, retention (target ≥80%), and adherence (target ≥75% with biomarker concordance) and obtain effect-size/variance for MRI-PDFF; MRE/ALT exploratory. (2) Mechanistic pathways—identify reproducible microbiome/metabolomic/proteomic signatures associated with the bean substitution and imaging signals. (3) Acceptability & PROs—determine acceptability (benchmark ≥70%) and changes in PRO domains, integrating qualitative feedback to optimize implementation. Designed for estimation rather than hypothesis testing, this randomized feasibility trial will deliver feasibility precision targets, MRI-PDFF effect-size/variance, a biomarker-anchored adherence framework, pathway-level signals, and patient-centered implementation guidance—positioning a larger, multi-site efficacy trial and informing scalable, food-as-medicine strategies for people with MASLD and F2–F3 fibrosis.
