[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"collagen-protein\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:collagen-protein":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},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).",[26,27,28,29,30,31,32],"Obesity & Overweight","Collagen Protein","Bariatric Surgery","Metabolic and Bariatric Surgery","Body Composition","Muscle Composition","Body Image",[28,34,35,30],"Collagen Supplementation","Muscle Mass","RECRUITING","2026-09-03",{"date":39,"type":40},"2026-09-09","ACTUAL",{"date":42,"type":40},"2026-07-01",{"date":44,"type":22},"2027-02-10",{"name":46,"class":47},"Mudanya University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100571809","phase-1-impact-of-recombinant-humanized-type-iii-collagen-on-the-immediate-and-long-term-effects-of-breast-tumor-surgery-100571809","NCT06725082","Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery","Impact of Recombinant Humanized Type III Collagen on the Immediate and Long-term Effects of Breast Tumor Surgery: a Multicenter, Prospective, Randomized, Open-label, Parallel-controlled Trial Protocol","ColBreast","Inclusion Criteria:\n\n1. Females aged 18 years or older but not exceeding 80 years;\n2. Clinical and imaging diagnosis of breast tumor, planned for needle biopsy;\n3. Planned to undergo breast tumor surgery and may plan for whole-breast radiotherapy;\n4. No systemic anti-tumor treatment or local treatment (including chemotherapy and radiotherapy) has been received before screening;\n5. ECOG Performance Status (PS) - 0 or 1;\n6. Subjects voluntarily join this study and sign the informed consent form.\n\nExclusion Criteria:\n\na.Tumor-related symptoms and treatments\n\n1）Bilateral, multiple lesions; 2) Skin damage and ulceration on the affected side of the breast; b. History of allergy to collagen products or their excipients or severe allergic constitution; c. History of breast cancer or other malignant tumors; d. Positive serum pregnancy test or lactation; e. Use of anticoagulant drugs, such as aspirin and other non-steroidal anti-inflammatory drugs or antiplatelet drugs; f. With severe comorbidities, such as cardiovascular diseases, hematological diseases, autoimmune diseases, neurological or psychiatric disorders, etc.","FEMALE","80 Years",{"count":60,"type":22},30,"INTERVENTIONAL",[63],"PHASE1","Breast tumors, particularly breast cancer, are increasingly prevalent in China, with a noticeable trend towards younger ages. Preliminary research indicates that Type III Collagen (COL3) plays a crucial role in tissue and organ protection within the tumor microenvironment and can inhibit tumor progression through microenvironmental remodeling. However, there are no clinical studies related to COL3 in breast tumors. This project aims to initiate a multicenter, prospective, randomized, open-label, parallel-controlled trial by locally administering recombinant humanized Type III Collagen (rhCOL3) to patients undergoing breast tumor surgery. The study will observe the incidence of perioperative complications after rhCOL3 injection, as well as changes in aesthetic outcomes and tumor-related pathological indicators following breast tumor surgery with local rhCOL3 injection. The goal is to establish a targeted rhCOL3 local injection therapy with dual functions of local protection and synergistic treatment, providing a new strategy for the treatment of breast tumors.",[66,27],"Breast Cancer","2024-12-05",{"date":69,"type":40},"2024-12-10",{"date":71,"type":40},"2024-12-01",{"date":73,"type":22},"2028-12-30",{"name":75,"class":47},"Peking University People's Hospital"]