Isocaloric Navy-Bean Substitution in Adults With MASLD

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07730853
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dietary Supplement/Behavioral: Navy Bean-Rich Diet — OTHER
    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.
  • Habitual Diet (Control) — OTHER
    Participants maintain their usual diet without the navy-bean substitution during the assigned control period

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence A: Habitual Diet → Navy Bean-Rich Diet
    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).
  • Experimental: Sequence B: Navy Bean-Rich Diet → Habitual Diet
    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).

Primary Outcome Measure

Feasibility composite score [ Time Frame: Week 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Xiaotao Zhang, MD, PhD
[email protected]
212-659-5555
Siyang Shen, BS
[email protected]
Xiaotao Zhang (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Hospital· New York, NY

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