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.
Inclusion Criteria:
Exclusion Criteria:
Xiaotao.Zhang@mountsinai.org212-659-5555
with blinded central imaging reads and blinded outcome/laboratory assessment
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).
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).
Meena.Bansal@mssm.edu
Dietary Strategies for MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
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