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.
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
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
Crossover
Dietary Supplement/Behavioral: Navy Bean-Rich Diet
Other interventionIsocaloric 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.
Habitual Diet (Control)
Other interventionParticipants 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.
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.
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.
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.
Change in alanine aminotransferase (ALT)
Serum ALT (U/L) levels. Lower ALT indicates less hepatocellular injury.
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