[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628274":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":63,"collaborators":66,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":32,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Michigan State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Essential Amino Acids Supplementation","ACTIVE_COMPARATOR","The essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase.",[13],"Drug: Essential Amino Acids Supplementation intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Low Sugar Diet","The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.",[18],"Other: Low sugar diet",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Essential Amino Acids Supplementation intervention","EAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine",[9],[26,27],"EAA","AMS2392",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Low sugar diet","The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Miriam B Vos, MD, MSPH","PRINCIPAL_INVESTIGATOR",[38],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","616-267-2100","miriam.vos@msu.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Corewell Health West","RECRUITING","Grand Rapids","Michigan","49503","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-85.66809,42.96336,{"lat":55,"lon":54},[58,62],{"name":59,"role":39,"phone":60,"phoneExt":32,"email":61},"Renee Stuller, RN","616-391-2460","renee.stuller@corewellhealth.org",{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":36,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Miriam B. Vos","Principal Investigator",[67,69,70],{"name":68,"class":6},"Emory University",{"name":44,"class":6},{"name":71,"class":72},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100628274","phase-2-smart-diets-for-masld-100628274",false,"NCT07459504","SMART Diets for MASLD","A Sequential Multiple Assignment Randomized Trial of Diet Treatments for Hepatic Steatosis and Cardiometabolic Risk in Youth","Inclusion Criteria:\n\n* Children 11 to 17-years-old at the time of consenting\n* Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI\n* At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age\u002Fsex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130\u002F80 and\u002For signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU\u002FmL in prepubertal children and of 17 pIU\u002FmL and 13 pIU\u002FmL in pubertal girls and boys, respectively, OR Prediabetes)\n* ALT greater than or equal to 40 U\u002FL\n* Currently consumes greater than or equal to 2 eight-ounce sugar drinks (or juice) per week.\n* Patients of childbearing potential agrees to use adequate one or more effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n* Patients who are taking medications that can affect insulin (e.g., metformin, corticosteroids), most be on a stable dosage for at least 3 months prior to enrollment of the trial.\n* Written informed consent from parent or legal guardian, assent from child.\n\nExclusion Criteria:\n\n* Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of \\>6.5 mg\u002FdL at baseline\n* Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.\n* Patients unable to complete MRI or Labs required for the study.\n* Current participation in another clinical trial\n* Current participation in a weight loss program or obesity treatment program or clinic\n* Cancer or history of cancer within 5 years\n* Severe illness that required hospitalization in the last 60 days\n* Use of medications known to cause liver steatosis (TPN, amiodarone, chronic oral steroids, etc.)\n* Patients with implanted metal devices that are not compatible with magnetic resonance imaging (MRI).\n* Intellectual disability or major psychiatric disorder limiting informed assent\n* Clinical evidence of cirrhosis or advanced liver disease by any one of the following abnormal labs: (Hemoglobin less than 10 g\u002FdL, White blood cell less than 3,500 cells\u002Fmm, Neutrophil count less than 1,500 cells\u002Fmm3 of blood, Platelets less than 130,000 cells\u002Fmm3 of blood, Direct bilirubin greater than 1.0 mg\u002FdL)\n* Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range.\n* Albumin less than 3.2 g\u002FdL\n* A history of international normalized ratio (INR) greater than 1.4\n* AST or ALT greater than 250 IU\u002FdL.\n* Compensated or decompensated cirrhosis with evidence of portal hypertension.\n* Patients is pregnant or breastfeeding.\n* Patients who have been enrolled in a recent clinical trial and had the last dose of investigational product within 30 days or 5 half-lives of the study drug, whichever is longer.","ALL","11 Years","17 Years",{"count":84,"type":85},102,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and\u002For Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.",[91],"Metabolic-dysfunction Associated Steatotic Liver Disease",[93,94,95,96,97],"MASLD","Adolescents","Liver","Sugar","Amino acid supplement","2026-05-28",{"date":100,"type":101},"2026-06-01","ACTUAL",{"date":103,"type":85},"2026-06",{"date":105,"type":85},"2030-12-26",{"name":5,"class":6},1]