[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635941":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":35,"centralContacts":39,"locations":44,"responsibleParty":59,"collaborators":27,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":27,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Ball State University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Metabolically Healthy Obesity Group","EXPERIMENTAL","Individuals with a body mass index greater than 30 kg\u002Fm2 and 0-1 of the following risk factors: blood pressure \\>130\u002F85 mmHg, triglycerides \\> 150 mg\u002FdL, glucose \\> 100 mg\u002FdL, and HDL-C \\\u003C 50 (females) or \\\u003C 40 (males).",[13,14,15],"Dietary Supplement: Inulin Supplementation","Dietary Supplement: Maltodextrin (Placebo)","Other: High-fat meal",{"label":17,"type":18,"description":19,"interventionNames":20},"Metabolically Healthy Normal Weight Group","ACTIVE_COMPARATOR","Individuals with a body mass index between 18.5-24.9 kg\u002Fm2 and 0-1 of the following risk factors: blood pressure \\>130\u002F85 mmHg, triglycerides \\> 150 mg\u002FdL, glucose \\> 100 mg\u002FdL, and HDL-C \\\u003C 50 (females) or \\\u003C 40 (males).",[15],[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","Inulin Supplementation","Half of participants in part 2 will recieve supplemental inulin or placebo (maltodextrin).",[9],null,{"type":23,"name":29,"description":25,"armGroupLabels":30,"otherNames":27},"Maltodextrin (Placebo)",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":27},"High-fat meal","All participants in part 1 (both metabolically healthy normal weight and metabolically healthy obesity) will consume a high-fat meal designed to invoke changes in gut, immune, and vascular parameters.",[17,9],[36],{"name":37,"affiliation":5,"role":38},"Bryant Keirns, PhD","PRINCIPAL_INVESTIGATOR",[40],{"name":37,"role":41,"phone":42,"phoneExt":27,"email":43},"CONTACT","765-285-8356","bryant.keirns@bsu.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":27},"Health Professions Building","RECRUITING","Muncie","Indiana","47306","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-85.38636,40.19338,{"lat":57,"lon":56},{"type":38,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Bryant Keirns","Assistant Professor","100635941","gut-immune-and-vascular-health-in-metabolically-healthy-obesity-100635941",false,"NCT07559227","Gut, Immune, and Vascular Health in Metabolically Healthy Obesity","Impaired Gut-Vascular Axis as a Unique Driver of Cardiovascular Disease in Metabolically Healthy Obesity","Inclusion Criteria:\n\n* 18-55 years old.\n* BMI is 18.5-24.9 kg\u002Fm2 or \\>30kg\u002Fm2 (part 1). BMI \\> 30 kg\u002Fm2 (part 2)\n* Not pregnant or expecting to become pregnant (females only).\n* Not postmenopausal (females only).\n* Have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol (\"good cholesterol\").\n* Have not been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).\n* Have not been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease).\n* Do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit.\n* Have not taken antibiotics or probiotics in the last month.\n* Do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.\n* Do not use weight-loss drugs (e.g., Ozempic, Wegovy).\n* Have not had any surgery that alters the stomach\u002Fgastrointestinal tract (e.g., gastric sleeve, gastric bypass).\n* Do not use tobacco products or any illicit drugs.\n* Do not have a pacemaker.\n* Do not have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan\u002Fvegetarian diets, gluten-free diet, relevant food allergies).\n* Able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)\n\nExclusion Criteria:\n\n* Not 18-55 years old.\n* BMI is not 18.5-24.9 kg\u002Fm2 or \\>30kg\u002Fm2 (part 1). BMI is not \\> 30 kg\u002Fm2 (part 2)\n* Pregnant or expecting to become pregnant (females only).\n* Postmenopausal (females only).\n* Do not have 0-1 risk factors based on blood pressure, blood sugar, triglycerides, and HDL-cholesterol (\"good cholesterol\").\n* Have been diagnosed with an advanced cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes).\n* Have been diagnosed with a chronic inflammatory or gastrointestinal condition (e.g., rheumatoid arthritis, inflammatory bowel disease).\n* Regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs three days prior to the study visit.\n* Have taken antibiotics or probiotics in the last month.\n* Use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin), or anti-hypertensive drugs.\n* Use weight-loss drugs (e.g., Ozempic, Wegovy).\n* Have had any surgery that alters the stomach\u002Fgastrointestinal tract (e.g., gastric sleeve, gastric bypass).\n* Use tobacco products or any illicit drugs.\n* Have a pacemaker.\n* Have dietary restrictions prohibiting consumption of the provided meal (e.g., vegan\u002Fvegetarian diets, gluten-free diet, relevant food allergies).\n* Not able to stay in the supine position in the dark for at least 10 minutes (related to vascular measurements)",true,"ALL","18 Years","55 Years",{"count":74,"type":75},70,"ESTIMATED","INTERVENTIONAL",[78],"NA","The investigators seek to better understand how a single high-fat meal impacts gut, immune, and vascular outcomes in individuals with \"metabolically healthy obesity\" (obesity and largely normal cardiometabolic profile) and \"metabolically healthy normal-weight individuals.\" Second, the investigators seek to understand how a prebiotic fiber (inulin) impacts gut, immune, and vascular outcomes in individuals with \"metabolically healthy obesity.\"",[81],"Metabolically Healthy Obesity",[83,84,85,86],"Gut-vascular axis","Intestinal permeability","vascular function","obesity","2026-04-23",{"date":89,"type":90},"2026-04-30","ACTUAL",{"date":92,"type":90},"2026-03-01",{"date":94,"type":75},"2027-12",{"name":5,"class":6},1]