[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100210443":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":42,"locations":51,"responsibleParty":72,"collaborators":29,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":29,"enrollmentInfo":85,"targetDuration":29,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":54,"whyStopped":29,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"MeLT Dietary intervention","EXPERIMENTAL","Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.",[13],"Behavioral: MeLT Dietary intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"TLC Dietary intervention","Therapeutic Lifestyle Changes (TLC) diet. Used in cohorts 1, 2 and 3.",[18],"Behavioral: TLC Dietary intervention",{"label":20,"type":10,"description":21,"interventionNames":22},"MeLT dietary intervention with TMAO","Mediterranean Low TMAO diet with TMAO levels reported. Used in cohort 1 only.",[23],"Behavioral: MeLT dietary intervention with TMAO",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Mediterranean diet containing food with low TMAO content.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Standard American Heart Association (AHA) recommendations for dietary counseling.",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.",[20],[37,40],{"name":38,"affiliation":5,"role":39},"W. H. Wilson Tang, MD","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":5,"role":39},"Stanley L. Hazen, MD, PhD",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":29,"email":47},"Jennifer Wilcox, BA","CONTACT","216-636-6153","kirsopj@ccf.org",{"name":49,"role":45,"phone":46,"phoneExt":29,"email":50},"Valesha Province, MA","provinv@ccf.org",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-81.69541,41.4995,{"lat":64,"lon":63},[67,69,70],{"name":68,"role":45,"phone":46,"phoneExt":29,"email":47},"Jennifer D Wilcox, BA",{"name":38,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":71,"role":39,"phone":29,"phoneExt":29,"email":29},"Stanley L. Hazen, MD",{"type":39,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Wilson Tang","Staff Cellular and Molecular Medicine and Cardiovascular Medicine","100210443","gut-flora-metabolite-reduction-after-dietary-intervention-grady-100210443",false,"NCT02016430","Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)","GRADY","Inclusion Criteria:\n\nCohort 1 Inclusion criteria:\n\n* Men and women age 18 years or above.\n* Elevated TMAO metabolizers (\\>5 µM) based on screening test and\u002For eGFR \\\u003C 60 at most recent measurement.\n* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.\n* Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification.\n\nCohort 2 Inclusion criteria:\n\n* Men and women age 18 years or above.\n* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.\n* Willing to sign the consent form and follow the study protocol.\n* eGFR values ranging from 16-59\n\nCohort 3 Inclusion criteria:\n\n* Men and women age 18 years or above.\n* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.\n* Willing to sign the consent form and follow the study protocol.\n\nExclusion Criteria (all cohorts):\n\n* Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.\n* Active infection or received antibiotics within 2 months of study enrollment\n* Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days\n* Having undergone bariatric procedures or surgeries such as gastric banding or bypass.\n* Pregnancy.\n* Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial",true,"ALL","18 Years",{"count":86,"type":87},170,"ESTIMATED","INTERVENTIONAL",[90],"NA","Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.",[93,94],"Dietary Modification","Cardiovascular Risk Factor",[96,97,98,99,100],"TMAO","Gut Flora","Dietary Intervention","Choline","Carnitine","2026-06-23",{"date":103,"type":104},"2026-06-25","ACTUAL",{"date":106,"type":104},"2014-04-04",{"date":108,"type":87},"2026-12",{"name":5,"class":6},1]