NCT07730853Not yet recruiting
Isocaloric Navy-Bean Substitution in Adults With MASLD
Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07730853
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Sept 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.