[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623186":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":25,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Pharmanutra S.p.a.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Myosave®","EXPERIMENTAL","Participants receive Myosave® twice daily (two sachets\u002Fday) for 24 weeks, in addition to standard GLP-1 RA or dual GIP\u002FGLP-1 RA therapy.",[13],"Dietary Supplement: Myosave®",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP\u002FGLP-1 RA therapy.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Maria Sole Rossato","CONTACT","+390507846500","ms.rossato@pharmanutra.it",[37,57,72],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"IRCCS Auxologico","RECRUITING","Milan","20145","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],12.59836,42.78235,{"lat":48,"lon":47},[51,55],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Simona Bertoli, Prof.","+39 349 8130845","simona.bertoli@unimi.it",{"name":52,"role":56,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":39,"city":59,"state":25,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"IRCCS San Raffaele","Roma","00163",{"type":45,"coordinates":62},[63,64],11.10642,44.99364,{"lat":64,"lon":63},[67,71],{"name":68,"role":33,"phone":69,"phoneExt":25,"email":70},"Massimiliano Caprio, Prof.","+39 06 52253419","massimiliano.caprio@sanraffaele.it",{"name":68,"role":56,"phone":25,"phoneExt":25,"email":25},{"facility":73,"status":39,"city":74,"state":25,"zip":75,"country":42,"countryCode":43,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"IRCCS Istituto Clinico Humanitas","Rozzano","20089",{"type":45,"coordinates":77},[78,79],9.1559,45.38193,{"lat":79,"lon":78},[82,86],{"name":83,"role":33,"phone":84,"phoneExt":25,"email":85},"Roberto Vettor, Prof.","+39 3356108167","roberto.vettor@humanitas.it",{"name":83,"role":56,"phone":25,"phoneExt":25,"email":25},{"type":88,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[90],{"name":91,"class":6},"Sintesi Research Srl","100623186","effect-of-a-food-for-special-medical-purposes-on-muscle-mass-preservation-during-glp-1-ras-weight-loss-treatment-100623186",false,"NCT07393360","Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment","Evaluating the Effect of a Food for Special Medical Purposes Containing Essential Amino Acids (EAA), Carnitine, Arginine, and Sucrosomial Minerals on the Preservation of Appendicular Skeletal Muscle Mass (ASMM) During a Weight Loss Program With GLP-1 Receptor Agonists","MYO-PRESERVE","Inclusion Criteria:\n\n* Age ≥18 years and ≤ 65 years old;\n* BMI ≥ 30 Kg\u002Fm2 and ≤45 kg\u002Fm2\n* BMI from 27 kg\u002Fm2 to 30 Kg\u002Fm2 with at least one associated co-morbidity related to overweight \\[e.g. dysglycemia (pre-diabetes and\u002For metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\\], or cardiovascular disease\\]\n* Starting to use a GLP-1 RAs (liraglutide, semaglutide) or dual GIP and GLP-1 RAs (tirzepatide) for weight reduction; patient can be enrolled if they start the treatment at the time of enrollment or up to 2 weeks\n* Diet composition adjusted to provide 0.9-1.1 g\u002FKg ideal body weight proteins\n* Signed informed consent\n\nExclusion Criteria:\n\n* Type I and Type II diabetes; patients with pre-diabetes and\u002For metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled\n* Monogenic obesity (Subjects with a known diagnosis of monogenic obesity, including but not limited to pathogenic mutations in LEP, LEPR, MC4R, POMC, PCSK1, or other genes known to cause monogenic forms of early-onset or syndromic obesity)\n* Reduced kidney function, defined as eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation (see Appendix 1)\n* Oncologic patients in active treatments\n* Hypersensitivity to any of the constituents of the study product\n* Pregnancy\n* Breastfeeding\n* Use of meal replacements for a diet enriched with aminoacids and\u002For HMB\n* Use of food supplements containing aminoacids and\u002For HMB; patients can be included in the study if they undergo a washout period of at least 15 days","ALL","18 Years","65 Years",{"count":104,"type":105},144,"ESTIMATED","INTERVENTIONAL",[108],"NA","This study evaluates whether a Food for Special Medical Purposes (FSMP) can help to preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP\u002FGLP-1 receptor agonists. Participants will receive the FSMP or a matching placebo for 24 weeks while continuing standard GLP-1-based therapy. ASMM will be measured using Bioelectrical Impedance Vector Analysis (BIVA).",[111],"Obesity & Overweight",[113,114,115,116,117],"Weight Loss","Muscle Mass Preservation","Obesity","Body Composition","BIVA","2026-03-20",{"date":120,"type":121},"2026-03-23","ACTUAL",{"date":123,"type":121},"2025-12-11",{"date":125,"type":105},"2026-12",{"name":5,"class":6},3]