[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441247":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":32,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":32,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":32,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HA35 Placebo Group","PLACEBO_COMPARATOR","12 study participants will be given a placebo capsule to take once per day in the morning with breakfast for 3 days.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"HA35 Treatment Group","ACTIVE_COMPARATOR","12 study participants will be given an HA35 capsule to take once per day in the morning with breakfast for 3 days.",[19],"Drug: Sodium Hyaluronate",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sodium Hyaluronate","Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.",[15],[27],"HA35",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","A placebo will be given in capsule form to study participants.",[9],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Srinivasan Dasarathy, MD","CONTACT","216-318-7010","dasaras@ccf.org",{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},"Annette Bellar","bellara@ccf.org",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.69541,41.4995,{"lat":55,"lon":54},[58],{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Srinivasan Dasarathy","Staff Physician","100441247","early-phase-1-ha35-acute-alcohol-study-100441247",false,"NCT05025865","HA35 Acute Alcohol Study","Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls","Inclusion Criteria:\n\n* Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men\n* Ability to understand and willingness to provide written consent\n\nExclusion Criteria:\n\n* Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)\n* Poorly controlled diabetes (Hemoglobin A1c \\>9.5 g\u002Fdl)\n* Untreated hyper\u002Fhypothyroidism\n* Uncontrolled hypertension or hypercholesterolemia\n* End-stage renal disease\n* Liver disease of any etiology\n* Coronary artery disease or stroke\n* Active intravenous drug use\n* History of gastric bypass\n* Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)\n* Pregnancy\n* Past alcohol use disorder\n* Abnormal clotting factors",true,"ALL","21 Years","65 Years",{"count":75,"type":76},24,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","Eligible subjects will be asked to take a placebo\u002Ftreatment capsule for a total of 3 days and then participate in a study visit on the fourth day. This study visit will include a medical exam, clinical labs, questionnaires, body composition measurements, and urine and stool collections. Additionally, participants will consume a sugar cocktail to measure their gut permeability, participate in an acute ethanol challenge, and undergo two muscle biopsies. The study will take approximately 3-4 hours and a designated driver will need to drive the participant home. On the fifth day, you will be asked to return to drop of the 24-hour urine collection.",[82],"Healthy Controls","2025-11-14",{"date":85,"type":86},"2025-11-17","ACTUAL",{"date":88,"type":86},"2022-02-01",{"date":90,"type":76},"2027-10-01",{"name":5,"class":6},1]