[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511160":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Amino Acid Supplement","ACTIVE_COMPARATOR","Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants",[13],"Drug: Essential Amino Acid Supplement by Amino Co",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants",[19],"Other: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Essential Amino Acid Supplement by Amino Co","2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA",[9],[27,28],"Essential Amino Acid Supplement (EAA)","AMS22392",{"type":6,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Melanie Cree, MD, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Yesenia Garcia Reyes, MS","CONTACT","720-777-6984","yesenia.garciareyes@childrenscolorado.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Univeristy of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-104.83192,39.72943,{"lat":56,"lon":55},[59,60],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},{"name":61,"role":36,"phone":32,"phoneExt":32,"email":32},"Melanie Cree, MD,PhD",{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[65],{"name":66,"class":67},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100511160","phase-3-effect-of-amino-acids-on-hepatic-fat-content-in-adolescents-aminos-study-100511160",false,"NCT05935826","Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)","AMINOS","Inclusion Criteria\n\n* Ages 13-18, Tanner stage 4-5\n* Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \\>5.5%\n* Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist\n* Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week\n* BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories\n\nExclusion Criteria\n\n* Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.\n* Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study\n* Severe illness requiring hospitalization within 60 days\n* Diabetes, defined as Hemoglobin A1C \\> 6.4%\n* BMI percentile less than the 85th percentile for age and sex. Waist circumference \\>200 cm\n* Anemia, defined as Hemoglobin \\\u003C 11 mg\u002FdL\n* Diagnosed major psychiatric or developmental disorder limiting informed consent\n* Implanted metal devices that are not compatible with MRI\n* Use of blood pressure medications\n* Known liver disease other than NAFLD or AST or ALT \\>150 IU\u002FL","ALL","13 Years","18 Years",{"count":79,"type":80},55,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo \"fake supplement\" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.",[86,87,88],"Hepatic Steatosis","NAFLD","Adolescent Obesity",[9],"2025-08-21",{"date":92,"type":93},"2025-08-28","ACTUAL",{"date":95,"type":93},"2024-06-18",{"date":97,"type":80},"2026-08-31",{"name":5,"class":6},1]