[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468770":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":31,"responsibleParty":47,"collaborators":22,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":22,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":22,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":22,"overallStatus":68,"whyStopped":22,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Genomatica Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Avela™ (R)-1,3-Butanediol","EXPERIMENTAL","3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol \\[total intake of 34.5 g of (R)-1,3-butanediol\\].",[13],"Dietary Supplement: (R)-1,3-butanediol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","(R)-1,3-butanediol","Avela™ (R)-1,3-butanediol is intended to induce ketosis in the general adult population. Avela™ (R)-1,3-butanediol is GRAS for use in beverages, bars, and gels",[9],[21],"Avela",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"James Lowder, MD","CONTACT","619-387-7120","research@impactsciencealliance.org",{"name":30,"role":26,"phone":27,"phoneExt":22,"email":28},"Vassili Kotlov",[32],{"facility":33,"status":22,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Moniker Commons","San Diego","California","92106","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-117.16472,32.71571,{"lat":43,"lon":42},[46],{"name":30,"role":26,"phone":22,"phoneExt":22,"email":28},{"type":48,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100468770","an-open-label-acute-clinical-trial-to-assess-the-level-of-ketone-production-following-consumption-of-avela-r-13-butanediol-in-an-adult-population-100468770",false,"NCT05384106","AN OPEN-LABEL, ACUTE CLINICAL TRIAL TO ASSESS THE LEVEL OF KETONE PRODUCTION FOLLOWING CONSUMPTION OF AVELA™ (R)-1,3-BUTANEDIOL IN AN ADULT POPULATION","Inclusion Criteria:\n\n* Males and females, 18 to 65 years of age\n* BMI 18 to \\\u003C35.0 kg\u002Fm2, inclusive\n* Weight ≥ 110 lbs\n* Subject is judged to be in good health on the basis of medical history\n* Subject is willing to fast for 12 hours prior to study start\n* Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing\n* Subject is capable of giving informed consent and complying with all study procedures\u002Frequirements.\n\nExclusion Criteria:\n\n* Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)\n* Gastroenteritis in the 2 weeks preceding the study\n* Diabetes\n* Weight \\\u003C110 lbs\n* History of alcohol or drug abuse\n* Previous diagnosis of neurological disorders, depression, or mental illness with psychosis\n* Unexplained alarm features (i.e., unintentional weight loss \\>10% body weight in the last 3 months, fevers, or blood in stools)\n* Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study\n* Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)\n* Allergy to tree nuts\n* Women who are pregnant or breastfeeding\n* Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.",true,"ALL","18 Years","65 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64],"NA","The purpose of the pilot clinical trial described herein is to determine the level of ketone production \\[measured as β hydroxybutyrate (BHB)\\] following consumption of (R)-1,3-butanediol in a beverage and to record gastrointestinal (GI) symptomology, as well as any effects on alertness\u002Fsleepiness.",[67],"Healthy","UNKNOWN","2022-05-17",{"date":71,"type":72},"2022-05-20","ACTUAL",{"date":74,"type":61},"2022-05-25",{"date":76,"type":61},"2022-06-30",{"name":5,"class":6},1]