[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592111":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":58,"centralContacts":63,"locations":69,"responsibleParty":87,"collaborators":39,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":39,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":39,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":39,"overallStatus":72,"whyStopped":39,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Chinese Academy of Sciences","OTHER_GOV",[8,15,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","PLACEBO_COMPARATOR","They will receive energy-restricted nutritional and lifestyle intervention and placebo",[13,14],"Behavioral: Energy-restricted nutritional and lifestyle intervention","Dietary Supplement: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"GLP-1RA Group","ACTIVE_COMPARATOR","They will receive an energy-restricted nutritional and lifestyle intervention , in conjunction with prescribed semaglutide therapy.",[13,20],"Drug: semaglutide",{"label":22,"type":23,"description":24,"interventionNames":25},"Probiotic Group","EXPERIMENTAL","They will receive an energy-restricted nutritional and lifestyle intervention and LC-19",[13,26],"Dietary Supplement: Probiotic",{"label":28,"type":29,"description":30,"interventionNames":31},"Healthy Comparators","OTHER","They will receive general lifestyle and nutritional education.",[32],"Behavioral: General lifestyle and nutritional education",[34,40,44,49,53],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","General lifestyle and nutritional education","Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.",[28],null,{"type":35,"name":41,"description":42,"armGroupLabels":43,"otherNames":39},"Energy-restricted nutritional and lifestyle intervention","Participants will receive dietary advice, behavioral 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.",[9,16,22],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":39},"DIETARY_SUPPLEMENT","Placebo","Participants will receive one bag (2 g; 1 × 10¹² CFU) daily of LC-19.",[9],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":39},"Probiotic","participants will receive daily one bag of LC-19 (10\\^12 cfu\u002Fbag).",[22],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":39},"DRUG","semaglutide","Participants will receive prescibed semaglutide therapy",[16],[59],{"name":60,"affiliation":61,"role":62},"Xu Lin, PhD","Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":39,"email":68},"Wanhui Kang, PhD","CONTACT","+86 86081210","kangwanhui@ucas.ac.cn",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences","RECRUITING","Hangzhou","Zhejiang","310024","China","CN",{"type":79,"coordinates":80},"Point",[81,82],120.16142,30.29365,{"lat":82,"lon":81},[85,86],{"name":65,"role":66,"phone":67,"phoneExt":39,"email":68},{"name":60,"role":62,"phone":39,"phoneExt":39,"email":39},{"type":62,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Xu Lin","Principal Investigator","100592111","probiotic-intervention-on-body-weight-100592111",false,"NCT06989177","Probiotic Intervention on Body Weight","An Interventional Study Investigating the Effects of Probiotics 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":102,"type":103},140,"ESTIMATED","INTERVENTIONAL",[106],"NA","This study is a randomized controlled trial with 120 overweight or obese (body-mass index, BMI, ≥ 24 kg\u002Fm²) participants and 20 normal-weight participants. Twelve weeks of energy-restricted nutritional and lifestyle intervention with placebo, Lactobacillus paracasei LC-19 (LC-19), or semaglutide (a glucagon-like peptide-1 receptor agonist, GLP-1RA) will be randomly conducted in the overweight or obese participants. The primary goal is to clarify the roles of LC-19 and semaglutide in weight reduction and in improving energy, glucose, and lipid metabolism, while also comparing side effects, adverse events, and long-term outcomes such as weight regain between these two interventions. In addition, the study will explore key factors affecting intervention response to provide evidence for optimizing individualized intervention strategies.",[109,110,111,112],"Obesity","Homeostasis","Weight Loss","Probiotic Intervention","2026-03-16",{"date":115,"type":116},"2026-03-17","ACTUAL",{"date":118,"type":116},"2025-06-10",{"date":120,"type":103},"2026-12-31",{"name":5,"class":6},1]