[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617396":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":67,"collaborators":27,"id":69,"slug":27,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":27,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":27,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":27,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",[8,13,18],{"label":9,"type":10,"description":9,"interventionNames":11},"GI Health Product Placebo Control","PLACEBO_COMPARATOR",[12],"Dietary Supplement: GI Health Product Placebo Control",{"label":14,"type":15,"description":14,"interventionNames":16},"GI Health Active Product 2","EXPERIMENTAL",[17],"Dietary Supplement: GI Health Active Product 2",{"label":19,"type":15,"description":19,"interventionNames":20},"GI Health Active Product 1",[21],"Dietary Supplement: GI Health Active Product 1",[23,28,31],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","Participants will use their GI Health Product Placebo Control as directed for a period of 6 weeks",[9],null,{"type":24,"name":19,"description":29,"armGroupLabels":30,"otherNames":27},"Participants will use their GI Health Active Product 1 as directed for a period of 6 weeks",[19],{"type":24,"name":14,"description":32,"armGroupLabels":33,"otherNames":27},"Participants will use their GI Health Active Product 2 as directed for a period of 6 weeks",[14],[35],{"name":36,"affiliation":5,"role":37},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":27,"email":43},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":36,"role":41,"phone":45,"phoneExt":27,"email":46},"760-281-3898","susan.hewlings@radiclescience.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Radicle Science Inc.","RECRUITING","Del Mar","California","92014","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-117.26531,32.95949,{"lat":60,"lon":59},[63,64],{"name":40,"role":41,"phone":45,"phoneExt":27,"email":43},{"name":65,"role":41,"phone":27,"phoneExt":27,"email":66},"Megan Moseley","megan@radiclescience.com",{"type":68,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100617396",false,"NCT07318077","Radicle GI Health DBG: A Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes","Radicle GI Health DBG™: A Randomized, Double-Blind, Placebo Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on GI Health and Related Health Outcomes","Inclusion\n\nParticipants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n\n  * Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed\n* Resides in the United States\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\nExclusion\n\nIndividuals who report any of the following during screening may be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Unable to verify their identity during consent using Veriff\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English at approx. a 7th grade level\n* Reports a current and\u002For recent (up to 3 months ago) major illness and\u002For surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and\u002For a significant safety risk with any of the study product ingredients.\n\n  * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n  * Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of the primary ingredient(s) and\u002For similar product(s) to the active study product(s) that may limit the effects of the study products and\u002For pose a safety risk\n* Lack of reliable daily access to the internet",true,"ALL","21 Years","105 Years",{"count":80,"type":81},825,"ESTIMATED","INTERVENTIONAL",[84],"NA","Radicle GI Health DBG: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes.",[87,88],"Belly Pain","GI Health","2026-01-22",{"date":91,"type":92},"2026-01-23","ACTUAL",{"date":94,"type":92},"2026-01-06",{"date":96,"type":81},"2027-01-13",{"name":5,"class":6},1]