[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631071":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Hellenic Mediterranean University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GLP-1 + Standard Diet","ACTIVE_COMPARATOR","Participants will receive GLP-1 treatment alongside standard nutritional counseling based on the Mediterranean diet pattern, provided within the framework of usual clinical practice.",[13],"Behavioral: Control (Standard Mediterranean Diet Counseling)",{"label":15,"type":16,"description":17,"interventionNames":18},"GLP-1 + High Protein Diet","EXPERIMENTAL","Participants will receive GLP-1 treatment along with a specialized dietary intervention featuring individualized guidelines aimed at increasing daily protein intake.",[19],"Behavioral: High Protein Dietary Intervention",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","High Protein Dietary Intervention","Individualized dietary guidelines focusing on increased protein consumption to preserve muscle mass during weight loss.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control (Standard Mediterranean Diet Counseling)","Standard nutritional counseling based on the Mediterranean diet pattern as part of usual clinical practice.",[9],[32],{"name":33,"affiliation":5,"role":34},"Christopher Papandreou","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Ioanna Charalampidou","CONTACT","+302810379242","icharalampidou@hmu.gr",{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},[43,60],{"facility":44,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"1st Department of Internal Medicine, University General Hospital of Heraklion","RECRUITING","Heraklion","Greece","GR",{"type":50,"coordinates":51},"Point",[52,53],25.14341,35.32787,{"lat":53,"lon":52},[56,59],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":26},"Theodosios Filippatos","+302813402360",{"name":57,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":61,"status":45,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University",{"type":50,"coordinates":63},[52,53],{"lat":53,"lon":52},[66,68,69,71],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":67},"lab.bodycomp@hmu.gr",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":37,"role":70,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":26,"phoneExt":26,"email":26},"Vasileios Zafiropoulos",{"type":34,"investigatorFullName":33,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Assistant Professor, Department of Nutrition & Dietetics Sciences",[76],{"name":77,"class":6},"University General Hospital of Heraklion","100631071","effect-of-glp-1-receptor-agonists-on-body-composition-in-obesity-the-role-of-dietary-protein-consumption-in-muscle-mass-maintenance-100631071",false,"NCT07495904","Effect of GLP-1 Receptor Agonists on Body Composition in Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance","The Effect of GLP-1 Receptor Agonist-based Treatment on Body Composition and Muscle Mass in Adults With Obesity: The Role of Dietary Protein Consumption in Muscle Mass Maintenance","LEAN-PRO GLP-1","Inclusion Criteria:\n\n* Adults 30-65 years old\n* BMI: ≥30 kg\u002Fm²\n* Signed Informed Consent\n\nExclusion Criteria:\n\nA. Metabolic and Medical Conditions:\n\n* Uncontrolled type 2 diabetes (HbA1c \\> 9.0%)\n* Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4)\n* Chronic kidney disease stage 4-5 (GFR \\\u003C60 ml\u002Fmin)\n* Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN)\n* Inflammatory bowel disease\n* Celiac disease\n* History of pancreatitis\n* Any disorder potentially causing malabsorption\n* Active cancer or history of malignancy within the past 3 years\n* Psychiatric disorders affecting adherence or assessment B. Medication and Supplement Use\n* Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs)\n* Use of anti-inflammatory or antioxidant medications\n* Use of probiotics, prebiotics, or laxatives within the last month\n* Unstable medication regimen (changes within the past 3 months)\n* Use of protein and creatine supplements.\n\nC. Dietary and Lifestyle Factors:\n\n* Alcohol or substance abuse\n* Engagement in intense regular physical activity\n\nD. Reproductive Status:\n\n* Pregnancy or breastfeeding\n* Pregnancy within the past 12 months\n* Plans to become pregnant during the study\n\nE. Other:\n\n\\- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.","ALL","30 Years","65 Years",{"count":90,"type":91},130,"ESTIMATED","INTERVENTIONAL",[94],"NA","This study investigates how weight-loss medications, specifically GLP-1 receptor agonists, affect body composition, with a special focus on preserving muscle mass in adults with obesity. While these medications are highly effective for weight loss, they can sometimes lead to an unwanted loss of valuable muscle mass (a condition that can lead to sarcopenia).\n\nTo explore how to prevent this, researchers are conducting a 3- to 6-month randomized controlled trial involving adults aged 30 to 65 years with a BMI greater than 30 kg\u002Fm². Participants who are receiving GLP-1 medications will be randomly assigned to one of two groups: one group will receive the standard medication treatment alone, while the other group will receive the medication along with specific dietary guidance focused on increasing daily protein intake.",[97],"Obesity",[99,100,101,102,103],"Body composition","pharmacologically induced weight loss","GLP-1 receptor agonists","muscle mass","dietary protein","2026-03-28",{"date":106,"type":107},"2026-04-02","ACTUAL",{"date":109,"type":91},"2026-03-30",{"date":111,"type":91},"2029-01-30",{"name":5,"class":6},2]