[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626547":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":40,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":88,"whyStopped":40,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group Valine","EXPERIMENTAL","Daily oral consumption of 2 g valine, divided into two meals (1 g per meal, one packet), each equivalent to approximately 0.8 g of protein.",[13],"Drug: Valine",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment group EEA","Daily oral consumption of 20 g essential amino acids (EAA), divided into two meals (10 g per meal, one packet), each equivalent to 5 g of protein and 3.14 g of branched chain amino acids (BCAA).",[18],"Drug: EEA",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Valine","A medical food intended for use under medical supervision",[9],[26],"Valine Amino Acid Supplement",{"type":21,"name":28,"description":23,"armGroupLabels":29,"otherNames":30},"EEA",[15],[31],"Essential Amino Acid Supplement",[33],{"name":34,"affiliation":5,"role":35},"Subrata Debnath, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","210-567-4700",null,"nath@uthscsa.edu",[43],{"facility":5,"status":40,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"San Antonio","Texas","78229","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-98.49363,29.42412,{"lat":53,"lon":52},[56],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Subrata Debnath","Assistant Professor",[61],{"name":62,"class":63},"National Institute on Aging (NIA)","NIH","100626547","early-phase-1-sarcopenia-in-chronic-kidney-disease-ckd-patients-100626547",false,"NCT07437053","Sarcopenia in Chronic Kidney Disease (CKD) Patients","Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)","BOOST_CKD","Inclusion Criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document.\n2. Males and females of age 45-75 yrs\n3. Hand grip strength of \\\u003C26 kg for male and \\\u003C16 kg for female\n4. Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL\u002Fmin\u002F1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.\n5. Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months\n6. Receiving standard of care including dietary recommendation for diabetes, hypertension, CKD, and other comorbidities\n7. Patients who are on an SGLT2-i or GLP-1 agonist should be on a stable dose for at least 3 months prior randomization, with no dose adjustments expected in the next 4 months\n8. Serum HCO3 concentration 20-29 mmol\u002FL based on two consecutive recent routine labs\n9. HbA1c 7-9% based on most recent routine lab\n10. Serum albumin ≥3.8 g\u002FdL based on most recent routine lab\n11. Blood hemoglobin ≥10 g\u002FdL based on most recent routine lab\n12. Willingness to adhere to lifestyle management, including diet and exercise as recommended by care providers, and to the study intervention, procedures, and regimen.\n\nExclusion Criteria:\n\n1. Any known history of hypersensitivity\u002Fintolerance to valine or specific amino acids\n2. Any condition that may indicate the individual is not \"metabolically stable\" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months\n3. With a cardiac pacemaker and\u002For an implantable cardioverter-defibrillator\n4. Significant arthritis prohibiting strength test and walk gait speed test\n5. Significant comorbidities including heart failure (NY Class III or IV), neurological disorders, HIV AIDS, etiology of CKD other than diabetes and hypertension, or any condition that could compromise the subject's ability to study procedures as judged by study clinician\n6. Currently taking any protein supplements\n7. Pregnant, lactating, childbearing women\n8. History of Maple syrup urine disease (MSUD)\n9. Scheduled for kidney transplantation or dialysis in next 4 months\n10. Current participation in another interventional trial\n11. Documented noncompliance with regard to clinic visits, medications, and lifestyle management.\n12. Documentation of current or history of substance abuse.","ALL","45 Years","75 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"EARLY_PHASE1","Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.\n\nThe study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.",[83,84],"Chronic Kidney Disease","Sarcopenia",[22,86,87],"Essential amino acid","Metabolic effects","NOT_YET_RECRUITING","2026-08-07",{"date":91,"type":92},"2026-08-11","ACTUAL",{"date":94,"type":77},"2026-08-24",{"date":96,"type":77},"2027-10-30",{"name":5,"class":6},1]