[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07730853":3,"trial-entities:NCT07730853":156,"trial-summary:NCT07730853":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":14,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":48,"secondary_outcomes":53,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":105,"locations":108,"central_contacts":131,"overall_officials":136,"references":138,"see_also_links":152},"NCT07730853","GCO 25-1954","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)","NOT_YET_RECRUITING","2029-08-31","2026-07","2026-07-28","2026-09-01","Icahn School of Medicine at Mount Sinai","OTHER",true,"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.","Rationale: Diet acts on MASLD progression through the gut-liver axis, in which microbial composition, intestinal barrier integrity, and microbe-derived metabolites influence hepatic inflammation, steatosis, and fibrosis. Navy beans supply fermentable fiber, resistant starch, and polyphenols that nourish short-chain-fatty-acid-producing microbes, and prior human work (the BE GONE trial) demonstrated increased microbial diversity, enrichment of beneficial taxa, and favorable metabolomic and proteomic shifts following an 8-week navy-bean intervention. An isocaloric substitution approach isolates bean-specific biologic effects from weight change, addressing a major confounder in MASLD dietary trials.",[19,20,21],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Liver Fibrosis","Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[23,24,25,26,27,28],"Navy beans","Dietary intervention","Isocaloric substitution","Gut microbiome","Gut-liver axis","Liver stiffness","INTERVENTIONAL",[31],"NA",{"count":33,"type":34},40,"ESTIMATED",[36,44],{"type":14,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"Dietary Supplement\u002FBehavioral: Navy Bean-Rich Diet","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.",[40,41],"Sequence A: Habitual Diet → Navy Bean-Rich Diet","Sequence B: Navy Bean-Rich Diet → Habitual Diet",[43],"Navy Bean-Rich Diet",{"type":14,"name":45,"description":46,"armGroupLabels":47},"Habitual Diet (Control)","Participants maintain their usual diet without the navy-bean substitution during the assigned control period",[40,41],[49],{"measure":50,"description":51,"timeFrame":52},"Feasibility composite score","Feasibility is assessed as a composite of three pre-specified measure\n\n1. Recruitment velocity: number of participants randomized per month, calculated as total randomized divided by months of active enrollment.\n2. 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.\n3. 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.\n\nEach 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",[54,58,62,66,69],{"measure":55,"description":56,"timeFrame":57},"Proportion of participants rating the navy-bean intervention as acceptable","Proportion of participants rating the navy-bean intervention as acceptable, defined as a score ≥4 on a 5-point Likert scale (minimum 1 = least acceptable, maximum 5 = most acceptable; higher scores indicate greater acceptability) assessing taste, tolerability, and convenience.","At Week 12 and Week 24",{"measure":59,"description":60,"timeFrame":61},"Proportion of visits with Isocaloric fidelity","Proportion of visits at which energy intake is within ±5% of the prescribed target with body-weight change ≤2% per period, calculated from dietary recalls and serial weights. Higher values indicate better maintenance of isocaloric substitution.","through Week 24",{"measure":63,"description":64,"timeFrame":65},"Change in hepatic fat by MRI-PDFF","Within-person difference in hepatic fat, measured as MRI proton density fat fraction (percent) from blinded central reads, comparing the navy-bean condition to the habitual condition. Lower MRI-PDFF indicates less hepatic steatosis.","Baseline (Week 0), Week 12, and Week 24",{"measure":67,"description":68,"timeFrame":65},"Change in alanine aminotransferase (ALT)","Serum ALT (U\u002FL) levels. Lower ALT indicates less hepatocellular injury.",{"measure":70,"description":71,"timeFrame":65},"Change in liver stiffness by MRE","Liver stiffness (kPa) by magnetic resonance elastography. Lower stiffness indicates less fibrosis burden.","ALL","18 Years","75 Years",false,{"inclusion":77,"exclusion":87,"raw_text":104},[78,79,80,81,82,83,84,85,86],"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\u002Fm²","Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management","Alcohol intake below MASLD thresholds (≤15 drinks\u002Fweek for men, ≤10 drinks\u002Fweek for women)","Willing and able to consume study navy beans and complete dietary recalls (ASA-24\u002FDSQ)","Able to undergo MRI and MRE (no contraindications) and attend study visits","Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes",[88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"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\u002FC cirrhosis, or clinical portal hypertension\u002Fdecompensation","Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months","Legume\u002Fbean 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\u002Fprobiotics)","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 \\\u003C45), 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","Inclusion Criteria:\n\n* Adults 18-75 years of age with capacity to provide informed consent\n* 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\n* 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\n* Body mass index 25-45 kg\u002Fm²\n* Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management\n* Alcohol intake below MASLD thresholds (≤15 drinks\u002Fweek for men, ≤10 drinks\u002Fweek for women)\n* Willing and able to consume study navy beans and complete dietary recalls (ASA-24\u002FDSQ)\n* Able to undergo MRI and MRE (no contraindications) and attend study visits\n* Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes\n\nExclusion Criteria:\n\n* Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)\n* Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B\u002FC cirrhosis, or clinical portal hypertension\u002Fdecompensation\n* Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months\n* Legume\u002Fbean allergy or intolerance\n* Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial\n* Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks\n* Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)\n* New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre\u002Fprobiotics)\n* Antibiotics, probiotics, or colonoscopy preparation within 8 weeks\n* Planned bariatric surgery or other major weight-loss intervention during the study\n* Recent weight change \\>5% within 8-12 weeks prior to baseline\n* Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance\n* Uncontrolled diabetes (HbA1c \\>10%), severe renal dysfunction (eGFR \\\u003C45), or unstable cardiovascular, thyroid, or psychiatric illness\n* Pregnant or breastfeeding\n* Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)\n* Participation in another interventional study within the last 30 days",[106,107],"ADULT","OLDER_ADULT",[109],{"facility":110,"city":111,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":128},"Mount Sinai Hospital","New York","10029","United States",[115,121,125],{"name":116,"role":117,"phone":118,"phoneExt":119,"email":120},"Xiaotao Zhang, MD, PhD","CONTACT","212-659-5555","85555","Xiaotao.Zhang@mountsinai.org",{"name":122,"role":117,"phoneExt":123,"email":124},"Siyang Shen, BS","88369","Siyang.Shen@mountsinai.org",{"name":126,"role":127},"Xiaotao Zhang","PRINCIPAL_INVESTIGATOR",{"lat":129,"lon":130},40.71427,-74.00597,[132,133],{"name":116,"role":117,"phone":118,"email":120},{"name":134,"role":117,"email":135},"Meena Bansal","Meena.Bansal@mssm.edu",[137],{"name":116,"affiliation":13,"role":127},[139,143,146,149],{"pmid":140,"type":141,"citation":142},"38040541","BACKGROUND","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\u002Fj.ebiom.2023.104873. Epub 2023 Nov 30.",{"pmid":144,"type":141,"citation":145},"31852462","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\u002Fs12885-019-6400-z.",{"pmid":147,"type":141,"citation":148},"30583518","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\u002Fnu11010028.",{"pmid":150,"type":141,"citation":151},"40632657","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\u002FHEP.0000000000001462. Epub 2025 Jul 9.",[153],{"label":154,"url":155},"Funding announcement: NIH PAS-25-102","https:\u002F\u002Fgrants.nih.gov\u002Fgrants\u002Fguide\u002Fpa-files\u002FPAS-25-102.html",{"nct_id":4,"conditions":157,"biomarkers":160},[158,159],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Steatohepatitis",[],{"nct_id":4,"found":15,"summary":162,"prompt_version":172},{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"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.","completed","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.","The primary goal is measured at Week 24, which is the end of the study period.",111,"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.","Not stated in the trial record.",[],"v2"]