Project Grant R01DK148865

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Icahn School of Medicine at Mount Sinai $672,000 on August 14, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to conduct a randomized feasibility trial testing isocaloric navy bean substitution as a dietary intervention in adults with metabolic dysfunction-associated steatotic liver disease and advanced fibrosis.

The recipient will conduct a single-site, 24-week, two-period, two-sequence randomized crossover study enrolling 40 participants from the Mount Sinai Steatotic Liver Disease Registry. The intervention replaces calories from habitual foods with navy beans to isolate weight-independent effects on hepatic steatosis. Primary feasibility endpoints are recruitment, retention (target 80%), and adherence (target 75%), with adherence verified through plasma pipecolic acid, a validated biochemical marker. The trial will measure hepatic fat by MRI proton-density fat fraction as the primary pilot biological signal, with exploratory assessment of liver stiffness and alanine aminotransferase given the fibrosis stage F2–F3 context. A prespecified carryover check with parallel-group fallback preserves unbiased inference. Multi-omics profiling of oral and gut microbiome, plasma metabolomics, and proteomics will identify pathway signatures linked to imaging endpoints and nominate biomarkers for future efficacy trials. Patient-reported outcomes and interviews will inform acceptability, tolerability, preferred food forms, and an implementation toolkit for real-world deployment across diverse populations.

Work is performed in New York, New York. The period of performance extends through June 30, 2029.