[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592113":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":53,"centralContacts":58,"locations":64,"responsibleParty":83,"collaborators":38,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":38,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":38,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":38,"overallStatus":67,"whyStopped":38,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Chinese Academy of Sciences","OTHER_GOV",[8,14,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"CRD","PLACEBO_COMPARATOR","They will receive calorie restricted balanced diet and placebo",[13],"Behavioral: Calorie-restricted balanced diet",{"label":15,"type":16,"description":17,"interventionNames":18},"CRD+GLP-1RA","ACTIVE_COMPARATOR","They will receive calorie restricted balanced diet and semaglutide",[13,19],"Drug: semaglutide",{"label":21,"type":22,"description":23,"interventionNames":24},"CRD+GLP-1RA+HP","EXPERIMENTAL","They will receive calorie restricted balanced diet, semaglutide, and 30g\u002Fday of dietary protein supplementation",[13,19,25],"Dietary Supplement: Dietary protein supplementation",{"label":27,"type":28,"description":29,"interventionNames":30},"Healthy Comparators","OTHER","They will receive general lifestyle and nutritional education.",[31],"Behavioral: General lifestyle and nutritional education",[33,39,43,48],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","General lifestyle and nutritional education","Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.",[27],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Calorie-restricted balanced diet","Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians. APP-connected wearable devices will be utilized to monitor their dietary intakes and APP-connected scale will be used to monitor their weight changes during interventions.",[9,15,21],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":38},"DRUG","semaglutide","Participants will receive semaglutide as medically prescribed",[15,21],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":38},"DIETARY_SUPPLEMENT","Dietary protein supplementation","participants will receive 30 g\u002Fday of dietary protein supplementation",[21],[54],{"name":55,"affiliation":56,"role":57},"Xu Lin, PhD","Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":38,"email":63},"Wanhui Kang, PhD","CONTACT","+86 86081210","kangwanhui@ucas.ac.cn",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Tongde Hospital of Zhejiang Province","RECRUITING","Hangzhou","Zhejiang","310024","China","CN",{"type":74,"coordinates":75},"Point",[76,77],120.16142,30.29365,{"lat":77,"lon":76},[80,81],{"name":60,"role":61,"phone":62,"phoneExt":38,"email":63},{"name":82,"role":57,"phone":38,"phoneExt":38,"email":38},"Xu Lin",{"type":57,"investigatorFullName":82,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Principal Investigator","100592113","protein-supplementation-intervention-on-body-weight-100592113",false,"NCT06989203","Protein Supplementation Intervention on Body Weight","An Intervention Study Investigating Effect of Dietary Protein Supplementation on Body Weight and Metabolic Homeostasis","Inclusion Criteria:\n\n* Aged 20 to 50 years.\n* Normal-weight participants: 18.5 kg\u002Fm² ≤ Body Mass Index (BMI) \\\u003C 24 kg\u002Fm².\n* Overweight or obese participants:\n\nBMI ≥ 28 kg\u002Fm², or 24 kg\u002Fm² ≤ BMI \\\u003C 28 kg\u002Fm² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).\n\n* Willingness to participate in this study and provide signed informed consent.\n\nExclusion Criteria:\n\n* Abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):\n\n  1\\. Normal weight (18.5 kg\u002Fm² ≤ BMI \\\u003C 24 kg\u002Fm²):\n  1. Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.\n  2. Fasting glucose ≥ 6.1 mmol\u002FL or 2-hour postprandial glucose ≥ 7.8 mmol\u002FL, or a confirmed diagnosis of diabetes.\n  3. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.\n  4. Fasting triglycerides (TG) ≥ 1.7 mmol\u002FL; high-density lipoprotein cholesterol (HDL-C) \\\u003C 0.9 mmol\u002FL in men or \\\u003C 1.0 mmol\u002FL in women.\n\n  2\\. Overweight or obese (BMI ≥ 24 kg\u002Fm²):\n  1. Fasting plasma glucose \\> 11.1 mmol\u002FL or HbA1c \\> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.\n  2. Blood pressure ≥ 160\u002F100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.\n  3. Use of lipid-lowering drugs (e.g., fibrates, bile acid sequestrants, statins, PCSK9 inhibitors) within the past 3 months, or TG ≥ 5.7 mmol\u002FL, or LDL ≥ 4.9 mmol\u002FL.\n* Pregnancy or lactation.\n* Self-reported weight change of more than 5 kg within the 90 days prior to screening.\n* Use of antibiotics, antimicrobials, or anti-inflammatory\u002Fanalgesic salicylates (e.g., aspirin) within the 3 months prior to screening for 3 days or more.\n* Use of estrogen therapy or other hormonal medications within the past 6 months.\n* Use of GLP-1 receptor agonists or probiotics within the past 3 months.\n* Heavy alcohol consumption (females \\> 40 g\u002Fday, approximately 250 mL of huangjiu \\[yellow rice wine\\], or 1000 mL of beer, or 100 mL of liquor per day; males \\> 80 g\u002Fday).\n* Severe liver or kidney dysfunction (ALT, AST, or serum creatinine exceeding 3 times the upper limit of normal, UACR ≥ 30 mg\u002Fg, or eGFR \\\u003C 60 mL\u002Fmin).\n* Gastrointestinal diseases affecting digestion and absorption (e.g., severe diarrhea, severe constipation, severe inflammatory bowel disease, peptic ulcer, gallstones, cholecystitis).\n* Underwent surgery within the past year (excluding appendectomy or hernia repair).\n* Severe cardiovascular or cerebrovascular diseases (e.g., heart failure, myocardial infarction, stroke, acute myocarditis, severe arrhythmia, or receiving interventional therapy).\n* Presence of metallic implants such as a cardiac stent or pacemaker.\n* Cancer or having received radiation or chemotherapy within the past 5 years.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, or a personal history of hyperthyroidism or hypothyroidism.\n* Chronic or acute pancreatitis.\n* Positive hepatitis B surface antigen (HBsAg), active tuberculosis, HIV, or other infectious diseases.\n* Currently participating in another clinical study or having done so within the past 3 months.\n* Claustrophobia.\n* Any psychiatric disorder such as attention-deficit\u002Fhyperactivity disorder (ADHD), bipolar disorder, or epilepsy (including current use of antiepileptic medications), or use of antidepressant medications.\n* Inability to read, write, operate a smartphone, or perform daily activities independently.",true,"ALL","20 Years","50 Years",{"count":97,"type":98},140,"ESTIMATED","INTERVENTIONAL",[101],"NA","This study is a randomized clinical trail with a parallel design, involving 120 overweight\u002Fobese (body-mass index, BMI ≥ 24 kg\u002Fm²) participants and 20 normal-weight participants. Overweight\u002Fobese participants will be randomly allocated to one of three groups: 1) calorie restricted balanced diet (CRD)group; 2) CRD + semaglutide group; or 3) CRD + segaglutide with protein supplementation. Through a 3-month weight loss intervention and 6-month follow-up, this study aims to investigate the effects of dietary protein supplementation combined with semaglutide on weight loss, energy and glucose and lipid metabolism, muscle loss, and weight regain. Additionally, the study will explore key factors affecting intervention efficacy, including obesity phenotypes, gut microbiota profiles, genetic backgrounds, and lifestyle factors, to provide evidence for optimizing individualized intervention strategies.",[104,105,106],"Obesity","Weight Loss","Protein Supplementation","2026-03-16",{"date":109,"type":110},"2026-03-17","ACTUAL",{"date":112,"type":110},"2025-06-10",{"date":114,"type":98},"2026-12-31",{"name":5,"class":6},1]