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Navy Bean Diet for MASLD and Liver Fibrosis

This study is looking at whether eating navy beans can help adults with metabolic dysfunction-associated steatotic liver disease (MASLD), also known as fatty liver disease, and intermediate-stage liver scarring (fibrosis). You would be asked to replace some of your usual diet with navy beans, while keeping your total calorie intake the same. This is done with guidance from a dietitian. The study wants to see if this navy bean diet is practical and acceptable to participants. To join, you must be 18-75 years old, have MASLD confirmed by imaging or biopsy, and have intermediate-stage fibrosis (F2-F3). The study is currently unclear on its recruitment status and plans to enroll 40 people.

Study design
This is a 24-week randomized crossover study, meaning you would try both the navy bean diet and your usual diet at different times. Forty participants will be enrolled.
What's involved
You would follow a navy bean-rich diet for 12 weeks and your usual diet for 12 weeks, with guidance from a dietitian. The study lasts for 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at Week 24, which is the end of the study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07730853

Isocaloric Navy-Bean Substitution in Adults With MASLD

Not Yet Recruiting
NAAges 18–75Interventional
Icahn School of Medicine at Mount Sinai
~40 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Dietary Supplement/Behavioral: Navy Bean-Rich DietHabitual Diet (Control)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility composite score
Measured over Week 24

Conditions

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

Explore related trials

Nonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Xiaotao Zhang, MD, PhD
[email protected]
212-659-5555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 18-75 years of age with capacity to provide informed consent
Enrolled in the Mount Sinai Steatotic Liver Disease registry with a clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior 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
Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management
Alcohol intake below MASLD thresholds (≤15 drinks/week for men, ≤10 drinks/week for women)
Willing and able to consume study navy beans and complete dietary recalls (ASA-24/DSQ)
Able to undergo MRI and MRE (no contraindications) and attend study visits
Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes

Exclusion

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
Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial
Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks
Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)
New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre/probiotics)
Antibiotics, probiotics, or colonoscopy preparation within 8 weeks
Planned bariatric surgery or other major weight-loss intervention during the study
Recent weight change \>5% within 8-12 weeks prior to baseline
Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance
Uncontrolled diabetes (HbA1c \>10%), severe renal dysfunction (eGFR \<45), or unstable cardiovascular, thyroid, or psychiatric illness
Pregnant or breastfeeding
Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)
Participation in another interventional study within the last 30 days

What this trial measures

  • Feasibility composite scoreWeek 24

    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.