[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100356728":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":35,"studyPopulation":35,"armGroups":42,"interventions":55,"overallOfficials":63,"centralContacts":68,"locations":73,"responsibleParty":91,"collaborators":35,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":35,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":35,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":35,"overallStatus":112,"whyStopped":35,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":35},[9,13,15,17,20,22,24,28,29,30,33,34],{"measure":10,"description":11,"timeFrame":12},"Mean Weight Change of Participants","Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.","Baseline to day 28",{"measure":10,"description":11,"timeFrame":14},"Day 28 to Day 42",{"measure":10,"description":11,"timeFrame":16},"Baseline to day 42",{"measure":18,"description":19,"timeFrame":12},"Diet-specific changes in secondary bile acid","The investigators will calculate changes in cholic acid in milligrams.",{"measure":18,"description":19,"timeFrame":21},"day 28 to day 42",{"measure":18,"description":19,"timeFrame":23},"baseline to day 42",{"measure":25,"description":26,"timeFrame":27},"Diet-specific changes in inflammatory marker","The investigators will calculate changes in c-reactive protein in mg\u002FL.","baseline to day 28",{"measure":25,"description":26,"timeFrame":21},{"measure":25,"description":26,"timeFrame":23},{"measure":31,"description":32,"timeFrame":27},"Diet-specific changes in short chain fatty acids","The investigators will calculate changes in acetic acid in mmol\u002FL",{"measure":31,"description":32,"timeFrame":21},{"measure":31,"description":32,"timeFrame":23},null,{"allocation":37,"interventionModel":38,"interventionModelDescription":35,"primaryPurpose":39,"observationalModel":35,"timePerspective":35,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":35,"whoMasked":35},"NONE",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"DASH diet","EXPERIMENTAL","calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber",[48],"Behavioral: DASH diet",{"label":50,"type":51,"description":52,"interventionNames":53},"standard American diet","ACTIVE_COMPARATOR","calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber",[54],"Behavioral: standard American diet",[56,60],{"type":57,"name":44,"description":58,"armGroupLabels":59,"otherNames":35},"BEHAVIORAL","brief description",[44],{"type":57,"name":50,"description":61,"armGroupLabels":62,"otherNames":35},"describe",[50],[64],{"name":65,"affiliation":66,"role":67},"Tiffany L Carson, PhD","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",[69],{"name":65,"role":70,"phone":71,"phoneExt":35,"email":72},"CONTACT","813-745-4944","Tiffany.Carson@moffitt.org",[74],{"facility":75,"status":35,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Moffit Cancer Center","Tampa","Florida","33612","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-82.45843,27.94752,{"lat":85,"lon":84},[88,90],{"name":89,"role":70,"phone":71,"phoneExt":35,"email":72},"Tiffany Carson, PhD",{"name":89,"role":67,"phone":35,"phoneExt":35,"email":35},{"type":92,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100356728","modifying-diet-to-improve-gut-microbiome-100356728",false,"NCT03924778","Modifying Diet to Improve Gut Microbiome","Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities","Inclusion Criteria:\n\n* female\n* non-Hispanic, black or white\n* age 19-65 years\n* BMI \\>= 30 kg\u002Fm\\^2\n* able to visit Bionutrition Unit daily\n\nExclusion Criteria:\n\n* gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps\n* antibiotic or probiotic use in the previous 90 days\n* tobacco use\n* heavy alcohol consumption\n* major medical conditions (e.g., renal disease, diabetes, cancer)",true,"FEMALE","18 Years",{"count":104,"type":105},28,"ESTIMATED","INTERVENTIONAL",[108],"NA","The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.",[111],"Obesity","NOT_YET_RECRUITING","2026-09-14",{"date":115,"type":116},"2026-09-17","ACTUAL",{"date":118,"type":105},"2027-07",{"date":120,"type":105},"2027-08",{"name":5,"class":6},1]