[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05025865":3,"trial-entities:NCT05025865":100,"trial-summary:NCT05025865":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":73,"locations":76,"central_contacts":91,"overall_officials":97,"references":98,"see_also_links":99},"NCT05025865","21-486","HA35 Acute Alcohol Study","Mechanisms by Which HA35 Regulates Muscle Protein Homeostasis in Healthy Controls","RECRUITING","2027-10-01","2025-11","2025-11-17","2022-02-01","The Cleveland Clinic","OTHER",false,"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.","Interested subjects will be assessed for eligibility and a written informed consent will be obtained. The screening visit will consist of a medical exam, clinical labs (if not available in medical record), and questionnaires. Those who pass the screening will be eligible for a baseline visit (may be combined with screening if appropriate labs are already done). The baseline visit will include collection of blood, urine, and stool samples, body composition measurements, and randomization into either HA35 or placebo groups. Patients will be instructed to take the HA35 or placebo daily in the morning before breakfast 3 days prior to the day 4 visit. Patients will be informed that they will need to have a driver that is known to them for the day 4 visit. In the morning of the day 4 visit, confirmation of a driver will occur prior to starting study procedures. During the day 4 visit, patients will have an acute ethanol challenge where they will need to consume 2mL\u002Fkg of vodka in 100mL of juice in under 60 minutes. Muscle biopsies will be collected before and after the challenge and blood will be collected throughout the day. In addition, patients will be given lactulose\u002Fmannitol\u002Fsucralose\u002Fsucrose cocktail to measure gut permeability. The costs of any of these tests\u002Fprocedures will not be billed to the patient and will be covered by the department. The participant will not be responsible for any costs.",[19],"Healthy Controls",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"EARLY_PHASE1",{"count":26,"type":27},24,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Sodium Hyaluronate","Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.",[34],"HA35 Treatment Group",[36],"HA35",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Placebo","A placebo will be given in capsule form to study participants.",[41],"HA35 Placebo Group",[43,47],{"measure":44,"description":45,"timeFrame":46},"Change in Aspartate Aminotransferase (AST)","change in units\u002Fliter (U\u002FL)","Baseline to day 4",{"measure":48,"description":45,"timeFrame":46},"Change in Alanine Aminotransferase (ALT)",[],"ALL","21 Years","65 Years",true,{"inclusion":55,"exclusion":58,"raw_text":72},[56,57],"Alcohol consumption of less than 7 drinks per week for women and less than 14 drinks per week for men","Ability to understand and willingness to provide written consent",[59,60,61,62,63,64,65,66,67,68,69,70,71],"Any known chronic illness including but not limited to cancer (except non-melanoma skin cancer)","Poorly controlled diabetes (Hemoglobin A1c \\>9.5 g\u002Fdl)","Untreated hyper\u002Fhypothyroidism","Uncontrolled hypertension or hypercholesterolemia","End-stage renal disease","Liver disease of any etiology","Coronary artery disease or stroke","Active intravenous drug use","History of gastric bypass","Medications known to alter muscle protein synthesis (systemic corticosteroids, tamoxifen, high dose estrogen, testosterone, or anabolic steroids)","Pregnancy","Past alcohol use disorder","Abnormal clotting factors","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",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":88},"Cleveland Clinic","Cleveland","Ohio","44195","United States",[84],{"name":85,"role":86,"email":87},"Annette Bellar","CONTACT","bellara@ccf.org",{"lat":89,"lon":90},41.4995,-81.69541,[92,96],{"name":93,"role":86,"phone":94,"email":95},"Srinivasan Dasarathy, MD","216-318-7010","dasaras@ccf.org",{"name":85,"role":86,"email":87},[],[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[19],[],{"nct_id":4,"found":53,"summary":104,"prompt_version":113},{"design":105,"status":106,"heading":6,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study that will enroll 24 healthy participants. You will be randomly assigned to receive either Sodium Hyaluronate or a placebo.","completed","This study is looking at how a capsule called Sodium Hyaluronate (HA35) might affect your liver after drinking alcohol. You could be eligible if you are a healthy adult between 21 and 65 years old, drink a moderate amount of alcohol, and don't have certain chronic illnesses. Participants will receive either Sodium Hyaluronate or a placebo (an inactive capsule). Researchers will measure changes in liver enzymes (Aspartate Aminotransferase or AST, and Alanine Aminotransferase or ALT) from the start of the study to day 4 to see if HA35 has an effect. The current status of this study is unclear, and it plans to enroll 24 healthy volunteers.","Your liver enzymes (AST and ALT) will be measured from baseline to day 4.",107,"You will take a capsule for 3 days, then have a 3-4 hour study visit on day 4 involving a medical exam, blood tests, questionnaires, body measurements, urine and stool collection, a sugar drink, an alcohol challenge, and two muscle biopsies. You will also need a designated driver for day 4 and will return on day 5 to drop off a 24-hour urine collection.","Not stated in the trial record.",[31,38],"v2"]