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Isocaloric Navy-Bean Substitution in Adults With MASLD

NCT07730853 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-12

No results posted yet for this study

Summary

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.

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
  • Liver Fibrosis
  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Interventions

OTHER

Dietary Supplement/Behavioral: Navy Bean-Rich Diet

Isocaloric 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.

OTHER

Habitual Diet (Control)

Participants maintain their usual diet without the navy-bean substitution during the assigned control period

Sponsors & Collaborators

Principal Investigators

  • Xiaotao Zhang, MD, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730853 on ClinicalTrials.gov