[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555030":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Oregon","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Garden First","EXPERIMENTAL","Participants assigned to this study arm undergo the Garden-fresh Produce intervention during the first period and the Supermarket Produce intervention during the second period.",[13,14],"Other: Garden-fresh Produce","Other: Supermarket Produce",{"label":16,"type":10,"description":17,"interventionNames":18},"Supermarket First","Participants assigned to this study arm undergo the Supermarket Produce intervention during the first period and the Garden-fresh Produce intervention during the second period.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Garden-fresh Produce","Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Supermarket Produce","Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Gwynne Mhuireach, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","541-346-4694","gwynhwyf@uoregon.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Institute for Health in the Built Environment, University of Oregon","RECRUITING","Eugene","Oregon","97403","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-123.08675,44.05207,{"lat":51,"lon":50},[54,55],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":31,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100555030","garden-fresh-foods-and-gut-microbiomes-100555030",false,"NCT06506786","Garden-fresh Foods and Gut Microbiomes","Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome","GFF","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to 35 or less than or equal to 18.\n* Age under 18 or over 45.\n* Female who is pregnant or lactating.\n* Irregular bowel movements and\u002For stool consistency.\n* Plans to travel, move residences, or other major life change during the study period (August-October 2023).\n* Unable to speak, read, and write English.\n* Use of any of the following drugs within the last 6 months:\n* systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);\n* oral, intravenous, intramuscular, nasal or inhaled corticosteroids;\n* cytokines;\n* methotrexate or immunosuppressive cytotoxic agents;\n* large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages\u002Fmilks, yogurts, foods do not apply.\n* Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.\n* History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.\n* Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.\n* Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.\n* Any confirmed or suspected condition\u002Fstate of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.\n* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.\n* History of active uncontrolled gastrointestinal disorders or diseases including:\n* inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;\n* irritable bowel syndrome (IBS) (moderate-severe);\n* persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);\n* chronic constipation.",true,"ALL","18 Years","45 Years",{"count":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.",[78],"Gut Microbiome","2024-07-16",{"date":81,"type":82},"2024-07-17","ACTUAL",{"date":84,"type":82},"2023-07-01",{"date":86,"type":72},"2024-12-31",{"name":5,"class":6},1]