[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589151":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":31,"locations":19,"responsibleParty":37,"collaborators":41,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":79,"whyStopped":19,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":19},{"fullName":5,"class":6},"Assuta Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Protein Supplementation and Resistance Training","EXPERIMENTAL","Participants in this arm will consume a daily dietary supplement of 25 grams of whey protein powder (Easy Whey) and participate in a structured resistance training program consisting of one guided online session per week, plus two additional independent sessions weekly, for a total duration of 6 months.",[13,14],"Dietary Supplement: Whey Protein Supplement","Behavioral: Resistance Training Program",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","NO_INTERVENTION","Participants in this arm will not receive protein supplementation or structured resistance training. They will be provided with general dietary recommendations at the beginning of the study and will continue their usual care for 6 months",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DIETARY_SUPPLEMENT","Whey Protein Supplement","Participants will take a daily supplement of whey protein powder (Easy Whey) providing 25 grams of protein each day for the duration of 6 months",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"BEHAVIORAL","Resistance Training Program","Participants will engage in resistance training consisting of one guided online session each week and two additional independent resistance training sessions weekly, totaling three sessions per week, for a duration of 6 months.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},"Shiri Sherf-Dagan, PhD","CONTACT","972525122203","shiris@ariel.ac.il",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Shiri Sherf Dagan","Dietitian and Epidemiologist",[42,45],{"name":43,"class":44},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",{"name":46,"class":6},"Ariel University","100589151","impact-of-protein-supplementation-and-resistance-training-on-body-composition-functional-parameters-metabolic-adaptation-and-nitrogen-balance-in-adults-aged-45-years-and-older-with-overweight-or-obesity-receiving-incretin-based-medications-100589151",false,"NCT06950684","Impact of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults Aged 45 Years and Older With Overweight or Obesity Receiving Incretin-based Medications","The Effect of Protein Supplementation and Resistance Training on Body Composition, Functional Parameters, Metabolic Adaptation, and Nitrogen Balance in Adults (Aged ≥45 Years) With Overweight\u002FObesity Receiving Incretin-Based Weight Loss Medication for 6 Months: A Multicenter RCT","PRIME","Inclusion Criteria:\n\n* Adults aged ≥45 years.\n* Overweight or obese (BMI ≥30, or BMI ≥27 with at least one obesity-related comorbidity).\n* Eligible to receive incretin-based weight loss medications (e.g. Wegovy or Mounjaro).\n* Able to read and speak Hebrew fluently.\n\nExclusion Criteria:\n\n* Medical contraindications for incretin-based weight-loss medications.\n* Current treatment with insulin or sulfonylurea medications.\n* Inflammatory bowel disease.\n* Active or unstable psychiatric disorders or cognitive impairment.\n* Active bulimia nervosa.\n* Previous bariatric surgery or bariatric endoscopic procedures.\n* Use of other weight management medications within the past month.\n* Weight loss of ≥5% within the past three months.\n* Implanted cardiac pacemaker or other electronic implants.\n* Regular resistance training within the past three months.\n* Regular use of protein supplements.\n* Allergy or intolerance to dairy proteins or vegan lifestyle.","ALL","45 Years",{"count":58,"type":59},180,"ESTIMATED","INTERVENTIONAL",[62],"NA","This study aim to evaluate the effects of protein supplements and resistance training on body composition, functional parameters, metabolic adaptation, and nitrogen balance in adults (aged ≥45 years) with overweight\u002Fobesity receiving weekly Incretin-Based obesity management medication treatment for 6 months.\n\nA parallel design, open-label, multicenter randomized controlled trial will be conducted among 240 patients (aged ≥45 years) initiating Incretin-Based obesity management medication. Participants will be recruited through obesity clinics at the Tel-Aviv Sourasky Medical Center and the Tel-Aviv Assuta Medical Center, obesity clinics of HMOs, and social media groups. They will be randomly assigned to one of two groups in a 1:1 ratio: protein supplements ('Easy Whey' 25 gr protein\u002Fday) plus weekly resistance training and no intervention. Data will be collected at baseline, 3, and 6 months, including demographics, medical status, body composition, functional parameters, resting metabolic rate, nitrogen balance, and physical activity performance.\n\nAll participants will be advised to follow an exercise regime, a reduced-calorie diet based on the principle of the Mediterranean eating pattern and be encouraged to follow a regular meeting schedule with a registered dietitian.",[65,66,67],"Obesity","Overweight (BMI &gt; 25)","Weight Loss",[69,70,71,72,73,74,75,76,77,78],"Protein supplementation","Resistance training","Body composition","Metabolic rate","Nitrogen balance","Incretin-based medications","Wegovy","Mounjaro","Older adults","Obesity treatment","NOT_YET_RECRUITING","2025-04-27",{"date":82,"type":83},"2025-04-30","ACTUAL",{"date":85,"type":59},"2025-07-01",{"date":87,"type":59},"2028-07-01",{"name":5,"class":6}]