[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555030":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":31,"interventions":43,"overallOfficials":52,"centralContacts":56,"locations":61,"responsibleParty":79,"collaborators":22,"id":81,"slug":22,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":22,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":22,"overallStatus":64,"whyStopped":22,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University of Oregon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":22},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Difference in fecal bacterial abundance, as characterized by qPCR with \"universal\" bacterial primers","ANOVA statistical test of bacterial gene copies (a proxy for absolute abundance) used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal bacterial abundance.","Baseline, 1 week, 3 weeks",{"measure":14,"description":15,"timeFrame":12},"Difference in fecal microbial diversity, as characterized by shotgun metagenomics.","ANOVA statistical test of Shannon index used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial diversity.",{"measure":17,"description":18,"timeFrame":12},"Difference in fecal microbial composition, as characterized by shotgun metagenomics.","PERMANOVA statistical test used to compare whether Garden-Fresh Produce and Supermarket Produce interventions differentially affect fecal microbial composition.",{"measure":20,"description":21,"timeFrame":12},"Presence of differentially abundant microbial taxa, as characterized by shotgun metagenomics.","Negative binomial GLM statistical test used to identify microbial taxa associated with either Garden-Fresh Produce or Supermarket Produce intervention.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","CROSSOVER","BASIC_SCIENCE",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"PARTICIPANT",[32,39],{"label":33,"type":34,"description":35,"interventionNames":36},"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.",[37,38],"Other: Garden-fresh Produce","Other: Supermarket Produce",{"label":40,"type":34,"description":41,"interventionNames":42},"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.",[37,38],[44,48],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":22},"Garden-fresh Produce","Participants are asked to consume the USDA-recommended amounts of fruits and vegetables harvested from their gardens.",[33,40],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":22},"Supermarket Produce","Participants are asked to consume the USDA-recommended amounts of fruits and vegetables purchased from a supermarket.",[33,40],[53],{"name":54,"affiliation":5,"role":55},"Gwynne Mhuireach, PhD","PRINCIPAL_INVESTIGATOR",[57],{"name":54,"role":58,"phone":59,"phoneExt":22,"email":60},"CONTACT","541-346-4694","gwynhwyf@uoregon.edu",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Institute for Health in the Built Environment, University of Oregon","RECRUITING","Eugene","Oregon","97403","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-123.08675,44.05207,{"lat":74,"lon":73},[77,78],{"name":54,"role":58,"phone":59,"phoneExt":22,"email":60},{"name":54,"role":55,"phone":22,"phoneExt":22,"email":22},{"type":80,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","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":93,"type":94},20,"ESTIMATED","INTERVENTIONAL",[97],"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.",[100],"Gut Microbiome","2024-07-16",{"date":103,"type":104},"2024-07-17","ACTUAL",{"date":106,"type":104},"2023-07-01",{"date":108,"type":94},"2024-12-31",{"name":5,"class":6},1]