[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650114":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":77,"collaborators":35,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":35,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":35,"overallStatus":99,"whyStopped":35,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Radicle Science","INDUSTRY",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Product 1A","EXPERIMENTAL","Active Fatigue Product 1A",[13],"Dietary Supplement: Active Fatigue Product 1A",{"label":15,"type":10,"description":16,"interventionNames":17},"Active Product 1B","Active Fatigue Product 1B",[18],"Dietary Supplement: Active Fatigue Product 1B",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Control 1A","PLACEBO_COMPARATOR","Placebo Fatigue Control 1A",[24],"Dietary Supplement: Placebo Fatigue Control 1A",{"label":26,"type":21,"description":27,"interventionNames":28},"Placebo Control 1B","Placebo Fatigue Control 1B",[29],"Dietary Supplement: Placebo Fatigue Control 1B",[31,36,39,42],{"type":32,"name":11,"description":33,"armGroupLabels":34,"otherNames":35},"DIETARY_SUPPLEMENT","Participants will use their Active Fatigue Product 1A as directed for a period of 8 weeks",[9],null,{"type":32,"name":16,"description":37,"armGroupLabels":38,"otherNames":35},"Participants will use their Active Fatigue Product 1B as directed for a period of 8 weeks",[15],{"type":32,"name":22,"description":40,"armGroupLabels":41,"otherNames":35},"Participants will use their Placebo Fatigue Control 1A as directed for a period of 8 weeks",[20],{"type":32,"name":27,"description":43,"armGroupLabels":44,"otherNames":35},"Participants will use their Placebo Fatigue Control 1B as directed for a period of 8 weeks",[26],[46],{"name":47,"affiliation":5,"role":48},"Susan Hewlings","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":35,"email":54},"Study Manager","CONTACT","858-779-0086","studymgmt@radiclescience.com",{"name":47,"role":52,"phone":56,"phoneExt":35,"email":57},"760-281-3898","susan.hewlings@radiclescience.com",[59],{"facility":60,"status":35,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Radicle Science Inc.","Del Mar","California","92014-2605","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-117.26531,32.95949,{"lat":70,"lon":69},[73,74],{"name":51,"role":52,"phone":56,"phoneExt":35,"email":54},{"name":75,"role":52,"phone":35,"phoneExt":35,"email":76},"Megan Moseley","megan@radiclescience.com",{"type":78,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100650114","radicle-energy-dnb-a-study-assessing-the-impact-of-health-and-wellness-products-on-fatigue-and-related-health-outcomes-100650114",false,"NCT07745010","Radicle Energy™ DNB: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes","Radicle Energy™ DNB: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes","\\- Inclusion\n\nParticipants must meet all the following criteria:\n\n* Adults, at least 40 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 PROs (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\n  * Exclusion\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* 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 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","40 Years","105 Years",{"count":91,"type":92},1320,"ESTIMATED","INTERVENTIONAL",[95],"NA","Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes",[98],"Fatigue","NOT_YET_RECRUITING","2026-07-29",{"date":102,"type":103},"2026-08-04","ACTUAL",{"date":105,"type":92},"2026-08-13",{"date":107,"type":92},"2027-08-13",{"name":5,"class":6},1]