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Navy beans take on fatty liver: a diet swap put to the test

NCT ID NCT07730853

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This trial tests whether replacing some of the usual diet with navy beans — without changing total calories — is a practical and acceptable way to help manage metabolic dysfunction-associated steatotic liver disease (MASLD) in adults with intermediate-stage liver fibrosis. Forty participants will follow either their normal diet or a navy-bean-rich diet for 12 weeks, then switch. The study focuses on whether people can stick with the diet and find it acceptable, not on whether it improves liver health directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a diet rich in navy beans, replacing an equal number of calories from the usual diet
What this could lead to
If the diet proves feasible and acceptable, it could point toward a simple, affordable dietary strategy to help manage fatty liver disease.
What could go wrong
This is a small early-stage trial focused on feasibility, not on proving the diet improves liver health. Results may not apply to everyone, and some people may find the diet hard to stick with.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Mount Sinai Hospital

    New York, New York, 10029, United States

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