[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655120":3},{"organization":4,"outcomesModule":7,"designInfo":105,"detailedDescription":104,"studyPopulation":108,"armGroups":109,"interventions":118,"overallOfficials":104,"centralContacts":124,"locations":133,"responsibleParty":150,"collaborators":104,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":104,"eligibilityCriteria":160,"healthyVolunteers":161,"sex":162,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":104,"studyType":168,"phases":104,"briefSummary":169,"conditions":170,"keywords":178,"overallStatus":136,"whyStopped":104,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Mudanya University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":39,"otherOutcomes":104},[9,13,17,20,24,27,30,33,36],{"measure":10,"description":11,"timeFrame":12},"Change in Body Weight","Body weight (kg) measured using a Tanita MC-780 MA device.","Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months",{"measure":14,"description":15,"timeFrame":16},"Change in Body Shape Questionnaire (BSQ) Score","Body image concerns were assessed using the Body Shape Questionnaire (BSQ-34), a validated instrument for the Turkish population. This 34-item self-report scale evaluates weight-related concerns and dissatisfaction with body shape over the preceding four weeks. Each item is scored from 1 (never) to 6 (always), with a total score range of 34 to 204. Higher scores indicate greater dissatisfaction with body shape, i.e., a worse outcome.","Preoperative and postoperative 6 months",{"measure":18,"description":19,"timeFrame":12},"Change in Body Mass Index (BMI)","BMI calculated as body weight (kg) divided by height squared (m²).",{"measure":21,"description":22,"timeFrame":23},"Percentage of Total Weight Loss (%TWL)","Calculated as (preoperative weight - postoperative weight) \u002F preoperative weight × 100.","Postoperative and 6 months",{"measure":25,"description":26,"timeFrame":23},"Percentage of Excess Weight Loss (%EWL)","Calculated as (preoperative weight - postoperative weight) \u002F (preoperative weight - ideal weight) × 100. Ideal body weight was calculated assuming a BMI of 25 kg\u002Fm².",{"measure":28,"description":29,"timeFrame":12},"Change in Fat Mass","Fat mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.",{"measure":31,"description":32,"timeFrame":12},"Change in Fat Mass Percentage","Fat mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.",{"measure":34,"description":35,"timeFrame":12},"Change in Muscle Mass","Muscle mass (kg) assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.",{"measure":37,"description":38,"timeFrame":12},"Change in Muscle Mass Percentage","Muscle mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.",[40,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101],{"measure":41,"description":42,"timeFrame":43},"Change in Fasting Blood Glucose","Fasting blood glucose (mg\u002FdL) obtained from routine clinical laboratory follow-up.","Preoperative and 6 months",{"measure":45,"description":46,"timeFrame":43},"Change in Fasting Insulin","Fasting insulin (µIU\u002FmL) obtained from routine clinical laboratory follow-up.",{"measure":48,"description":49,"timeFrame":43},"Change in HbA1c","Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.",{"measure":51,"description":52,"timeFrame":43},"Change in LDL Cholesterol","LDL cholesterol (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":54,"description":55,"timeFrame":43},"Change in HDL Cholesterol","HDL cholesterol (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":57,"description":58,"timeFrame":16},"Change in Triglycerides","Triglycerides (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":60,"description":61,"timeFrame":16},"Change in Total Cholesterol","Total cholesterol (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":63,"description":64,"timeFrame":43},"Change in ALT","Alanine aminotransferase (ALT, U\u002FL) obtained from routine clinical laboratory follow-up.",{"measure":66,"description":67,"timeFrame":43},"Change in AST","Aspartate aminotransferase (AST, U\u002FL) obtained from routine clinical laboratory follow-up.",{"measure":69,"description":70,"timeFrame":43},"Change in Uric Acid","Uric acid (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":72,"description":73,"timeFrame":43},"Change in Urea","Urea (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":75,"description":76,"timeFrame":43},"Change in Hemoglobin","Hemoglobin (g\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":78,"description":79,"timeFrame":43},"Change in Hematocrit","Hematocrit (%) obtained from routine clinical laboratory follow-up.",{"measure":81,"description":82,"timeFrame":43},"Change in Ferritin","Ferritin (ng\u002FmL) obtained from routine clinical laboratory follow-up.",{"measure":84,"description":85,"timeFrame":43},"Change in Serum Iron","Serum iron (µg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":87,"description":88,"timeFrame":43},"Change in Vitamin B12","Vitamin B12 (pg\u002FmL) obtained from routine clinical laboratory follow-up.",{"measure":90,"description":91,"timeFrame":43},"Change in Folic Acid","Folic acid (ng\u002FmL) obtained from routine clinical laboratory follow-up.",{"measure":93,"description":94,"timeFrame":43},"Change in Magnesium","Magnesium (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":96,"description":97,"timeFrame":43},"Change in Total Calcium","Total calcium (mg\u002FdL) obtained from routine clinical laboratory follow-up.",{"measure":99,"description":100,"timeFrame":43},"Change in Serum Sodium","Serum sodium (mEq\u002FL) obtained from routine clinical laboratory follow-up.",{"measure":102,"description":103,"timeFrame":43},"Change in Serum Potassium","Serum potassium (mEq\u002FL) obtained from routine clinical laboratory follow-up.",null,{"allocation":104,"interventionModel":104,"interventionModelDescription":104,"primaryPurpose":104,"observationalModel":106,"timePerspective":107,"maskingInfo":104},"COHORT","PROSPECTIVE","Adult patients aged 18-65 years who underwent sleeve gastrectomy and are under routine postoperative follow-up at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye. Eligible patients meet current ASMBS\u002FIFSO criteria for metabolic and bariatric surgery (BMI ≥ 35 kg\u002Fm², or BMI 30-34.9 kg\u002Fm² with an obesity-related metabolic comorbidity). Participants are naturally grouped according to their own preference to use or not use a collagen-containing supplement following surgery.",[110,115],{"label":111,"type":104,"description":112,"interventionNames":113},"1. Grup","Group\u002FCohort Label: Collagen Supplement Users (Kolajen Kullananlar) Description: Participants who, based on their own preference, use a collagen-containing supplement product following sleeve gastrectomy, without any intervention or recommendation from the study team.",[114],"Dietary Supplement: Collagen-containing supplement",{"label":116,"type":104,"description":117,"interventionNames":104},"2. Grup","Group\u002FCohort Label: Non-Users of Collagen Supplement (Kolajen Kullanmayanlar) Description: Participants who do not use any collagen-containing supplement product following sleeve gastrectomy, followed under routine clinical care.",[119],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":104},"DIETARY_SUPPLEMENT","Collagen-containing supplement","Collagen-containing supplement products used at the participants' own discretion following sleeve gastrectomy. The type of product, daily dosage, and duration of use were self-reported by participants",[111],[125,130],{"name":126,"role":127,"phone":128,"phoneExt":104,"email":129},"Seher Şen, Assistant Professor","CONTACT","+905393919700","seherdalli@gmail.com",{"name":131,"role":127,"phone":132,"phoneExt":104,"email":104},"Emre Şen, Master's degree graduate","0 532 163 30 87",[134],{"facility":135,"status":136,"city":137,"state":138,"zip":104,"country":139,"countryCode":104,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Yıldırım Doruk Hastanesi","RECRUITING","Bursa","Yıldırım","Turkey (Türkiye)",{"type":141,"coordinates":142},"Point",[143,144],29.06013,40.19559,{"lat":144,"lon":143},[147],{"name":104,"role":127,"phone":148,"phoneExt":104,"email":149},"05393919700","seher.sen@mudanya.edu.tr",{"type":151,"investigatorFullName":152,"investigatorTitle":153,"investigatorAffiliation":5,"oldNameTitle":104,"oldOrganization":104},"PRINCIPAL_INVESTIGATOR","Seher Şen","Assist. Prof. Dr.","100655120","collagen-supplements-and-post-mbs-muscle-massbody-image-100655120",false,"NCT07809152","Collagen Supplements and Post-MBS Muscle Mass\u002FBody Image","Relationship Between Collagen-Containing Supplement Use and Muscle Mass and Body Image Following Metabolic and Bariatric Surgery: A Prospective Observational Study","Inclusion Criteria:\n\n* Patients with a BMI ≥ 35 kg\u002Fm², regardless of the presence of comorbidities\n* Patients with a BMI of 30-34.9 kg\u002Fm² who have an obesity-related metabolic disease and are considered eligible for surgical treatment\n* Patients who have undergone metabolic and bariatric surgery (MBS) in accordance with current ASMBS\u002FIFSO guidelines (Eisenberg et al., 2022)\n* Patients under regular postoperative follow-up\n* Age 18-65 years\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* History of upper gastrointestinal bleeding\n* Severe psychiatric disorders\n* Active cancer diagnosis\n* Pregnancy or breastfeeding\n* Alcohol or substance dependence\n* Physical limitations preventing participation in exercise",true,"ALL","18 Years","65 Years",{"count":166,"type":167},52,"ESTIMATED","OBSERVATIONAL","This prospective, observational cohort study aims to evaluate whether the use of collagen-containing supplements is associated with differences in muscle mass, body composition, and body image among patients who have undergone sleeve gastrectomy (SG). The study will be conducted at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye, between May 2026 and March 2027, and will enroll adult patients (aged 18-65 years) who meet current ASMBS\u002FIFSO eligibility criteria for metabolic and bariatric surgery.\n\nParticipants will be naturally allocated into two observational groups based on their own choice to use or not use collagen-containing supplements; no supplement will be provided or recommended by the study team, and no intervention will be made to participants' standard clinical care. All patients will be followed according to routine clinical practice preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively.\n\nPrimary outcome measures include anthropometric parameters (body weight, BMI, fat mass, fat mass percentage, fat-free mass, muscle mass, percentage of weight loss, percentage of excess weight loss, waist and hip circumference) assessed via bioelectrical impedance analysis (Tanita MC-780 MA), and body image assessed using the Turkish-validated Body Shape Questionnaire (BSQ). Secondary outcomes include biochemical parameters, comorbidities, and macronutrient intake data obtained from 3-day dietary records analyzed using the BEBİS nutrition software.\n\nThe study hypothesizes that patients using collagen-containing supplements will show significant differences in muscle mass and body composition parameters compared with non-users, and that supplement use will be significantly associated with BSQ scores. A sample size of approximately 52 participants per group was calculated using G\\*Power 3.1 (one-way ANOVA, Cohen's f = 0.25, α = 0.05, power = 0.80).",[171,172,173,174,175,176,177],"Obesity & Overweight","Collagen Protein","Bariatric Surgery","Metabolic and Bariatric Surgery","Body Composition","Muscle Composition","Body Image",[173,179,180,175],"Collagen Supplementation","Muscle Mass","2026-09-03",{"date":183,"type":184},"2026-09-09","ACTUAL",{"date":186,"type":184},"2026-07-01",{"date":188,"type":167},"2027-02-10",{"name":5,"class":6},1]