About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dietary Supplement/Behavioral: Navy Bean-Rich Diet
- Habitual Diet (Control)