Isocaloric Navy-Bean Substitution in Adults With MASLD

NCT07730853 | Not Yet Recruiting DMC

• 1 other identifier: GCO 25-1954
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Navy beans; Dietary intervention; Isocaloric substitution; Gut microbiome; Gut-liver axis; Liver stiffness

Outcome Measures

Primary Outcomes (1)

• Feasibility composite score

  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.

  Week 24

Secondary Outcomes (5)

• Proportion of participants rating the navy-bean intervention as acceptable

  At Week 12 and Week 24

• Proportion of visits with Isocaloric fidelity

  through Week 24

• Change in hepatic fat by MRI-PDFF

  Baseline (Week 0), Week 12, and Week 24

• Change in alanine aminotransferase (ALT)

  Baseline (Week 0), Week 12, and Week 24

• Change in liver stiffness by MRE

  Baseline (Week 0), Week 12, and Week 24

Study Arms (2)

Sequence A: Habitual Diet → Navy Bean-Rich Diet

EXPERIMENTAL

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).

Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet; Other: Habitual Diet (Control)

Sequence B: Navy Bean-Rich Diet → Habitual Diet

EXPERIMENTAL

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).

Other: Dietary Supplement/Behavioral: Navy Bean-Rich Diet; Other: Habitual Diet (Control)

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.

Also known as: Navy Bean-Rich Diet

Sequence A: Habitual Diet → Navy Bean-Rich Diet; Sequence B: Navy Bean-Rich Diet → Habitual Diet

Habitual Diet (Control) OTHER

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

Sequence A: Habitual Diet → Navy Bean-Rich Diet; Sequence B: Navy Bean-Rich Diet → Habitual Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (4)

• Zhang X, Irajizad E, Hoffman KL, Fahrmann JF, Li F, Seo YD, Browman GJ, Dennison JB, Vykoukal J, Luna PN, Siu W, Wu R, Murage E, Ajami NJ, McQuade JL, Wargo JA, Long JP, Do KA, Lampe JW, Basen-Engquist KM, Okhuysen PC, Kopetz S, Hanash SM, Petrosino JF, Scheet P, Daniel CR. Modulating a prebiotic food source influences inflammation and immune-regulating gut microbes and metabolites: insights from the BE GONE trial. EBioMedicine. 2023 Dec;98:104873. doi: 10.1016/j.ebiom.2023.104873. Epub 2023 Nov 30.

  PMID: 38040541 BACKGROUND

• Zhang X, Browman G, Siu W, Basen-Engquist KM, Hanash SM, Hoffman KL, Okhuysen PC, Scheet P, Petrosino JF, Kopetz S, Daniel CR. The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. BMC Cancer. 2019 Dec 18;19(1):1233. doi: 10.1186/s12885-019-6400-z.

  PMID: 31852462 BACKGROUND

• Baxter BA, Oppel RC, Ryan EP. Navy Beans Impact the Stool Metabolome and Metabolic Pathways for Colon Health in Cancer Survivors. Nutrients. 2018 Dec 22;11(1):28. doi: 10.3390/nu11010028.

  PMID: 30583518 BACKGROUND

• Bajaj JS, Reddy KR, Tandon P, Lai JC, O'Leary JG, Wong F, Garcia-Tsao G, Vargas HE, Kamath PS, Biggins SW, Vutien P, Shaw J, Limon Miro AT, Bera C, McGinley JP, Sikaroodi M, Bush BJ, Thacker LR, Gillevet PM. Salivary microbiome and serum metabolomics add to clinical biomarkers to predict 6-month hospitalizations in a multicenter cirrhosis outpatient cohort. Hepatology. 2026 Jun 1;83(6):1483-1494. doi: 10.1097/HEP.0000000000001462. Epub 2025 Jul 9.

  PMID: 40632657 BACKGROUND

Related Links

• Funding announcement: NIH PAS-25-102

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Xiaotao Zhang, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaotao Zhang, MD, PhD

CONTACT

212-659-5555; Xiaotao.Zhang@mountsinai.org

Meena Bansal

CONTACT

Meena.Bansal@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: with blinded central imaging reads and blinded outcome/laboratory assessment
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

US (1)