[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639156":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":62,"studyPopulation":50,"armGroups":63,"interventions":76,"overallOfficials":84,"centralContacts":88,"locations":98,"responsibleParty":142,"collaborators":50,"id":144,"slug":50,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":50,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":50,"studyType":156,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":168,"whyStopped":50,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"change in concentrations of blood lipid levels in millimole per liter (mmol\u002FL).","change in total cholesterol and triglycerides levels from baseline to 4-month visit. The values will be reported in mmol\u002FL.","From enrollment to the end of intervention at 4 months",[14,17,20,23,26,29,32,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":12},"change in frequency of gastrointestinal symptoms","change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit",{"measure":18,"description":19,"timeFrame":12},"change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol\u002Fmol)","Description: change in concentration of glycosylated Hemoglobin A1c (HbA1c) from baseline to 4-month visit. The values will be reported in mmol\u002Fmol.",{"measure":21,"description":22,"timeFrame":12},"change in level of insulin resistance","Change in HOMA-IR (homeostatic model assessment of insulin resistance) and adipo-IR (adipose tissue insulin resistance index) from baseline to 4-month visit. HOMA-IR will be calculated based on fasting glucose (mmol\u002FL) and fasting insulin (mIU\u002FL). Adipo-IR will be estimated using fasting insulin (mIU\u002FL) and fasting free fatty acids (mmol\u002FL).",{"measure":24,"description":25,"timeFrame":12},"change in body weight in kilograms (kg)","Change in body weight (kg) from baseline to 4-month visit",{"measure":27,"description":28,"timeFrame":12},"change in body fat percentage (%)","change in body fat percentage from baseline to 4-month visit. The values will be reported in percentage (%).",{"measure":30,"description":31,"timeFrame":12},"change in waist circumference in centimeters (cm)","Change in waist Circumference (cm) from baseline to the 4-month visit.",{"measure":33,"description":34,"timeFrame":12},"change in level of gut microbiota abundance","Change in gut microbiota abundance from baseline to 4-month visit",{"measure":36,"description":37,"timeFrame":12},"change in level of gut microbiota diversity","Change in gut microbiota alpha and beta diversity from baseline to 4-month visit.",{"measure":39,"description":40,"timeFrame":12},"change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m²)","Change in estimated glomerular filtration rate (eGFR) from baseline to the 4-month visit. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI ) (2009) method will be used to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m²).",{"measure":42,"description":43,"timeFrame":12},"change in concentrations of liver function markers in units per liter (U\u002FL)","Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) from baseline to the 4-month visit. These values are reported in units per liter (U\u002FL).",{"measure":45,"description":46,"timeFrame":12},"change in level of C-reactive protein (CRP) in milligram per liter (mg\u002FL)","Change in C-reactive protein (CRP) from baseline to the 4-month visit. The value is reported in milligram per liter (mg\u002FL).",{"measure":48,"description":49,"timeFrame":12},"change in blood pressure in millimeters of mercury (mmHg)","Change in systolic and diastolic blood pressure from baseline to the 4-month visit. The values are reported in millimeters of mercury (mmHg).",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":56,"maskingDescription":50,"whoMasked":57},"QUADRUPLE",[58,59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications. Approximately 600 overweight or obese individuals using GLP-1 RA medications for weight loss will be enrolled. All participants will provide informed consent before randomization. Eligible individuals must be obese or be overweight with at least one body weight-related complications, and have been using GLP-1 RA medications at the time of enrollment for at least 3 months and plan to continue using them in the next 6 months. Eligible participants will be randomly assigned to inulin intervention or placebo group. Randomization will be computed within study center, age and sex groups. The intervention will last for 4 months. Questionnaire data and bio-samples will be collected before the start of intervention and at the end of the intervention. The primary outcomes are lipid levels measured in bio-samples. Data on secondary outcomes will be obtained through biomarker measurement and questionnaires.",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"inulin (prebiotics)","EXPERIMENTAL","The intervention dose is 10 grams per day. The intervention will last for 4 months.",[69],"Dietary Supplement: inulin (prebiotics)",{"label":71,"type":72,"description":73,"interventionNames":74},"maltodextrin","PLACEBO_COMPARATOR","The intake dose is 10 grams per day for 4 months.",[75],"Dietary Supplement: Placebo Comparator: maltodextrin",[77,80],{"type":78,"name":65,"description":67,"armGroupLabels":79,"otherNames":50},"DIETARY_SUPPLEMENT",[65],{"type":78,"name":81,"description":82,"armGroupLabels":83,"otherNames":50},"Placebo Comparator: maltodextrin","The dose is 10 grams per day for 4 months.",[71],[85],{"name":86,"affiliation":5,"role":87},"An Pan","PRINCIPAL_INVESTIGATOR",[89,94],{"name":90,"role":91,"phone":92,"phoneExt":50,"email":93},"Yuxia Wei, PhD","CONTACT","86-18813185223","2026020052@hust.edu.cn",{"name":95,"role":91,"phone":96,"phoneExt":50,"email":97},"An Pan, PhD","86-18186123783","panan@hust.edu.cn",[99,111,119,129,134],{"facility":100,"status":50,"city":101,"state":102,"zip":50,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":50},"The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture","Enshi","Hubei","China","CN",{"type":106,"coordinates":107},"Point",[108,109],109.48333,30.3,{"lat":109,"lon":108},{"facility":112,"status":50,"city":113,"state":102,"zip":50,"country":103,"countryCode":104,"cosmosGeoPoint":114,"geoPoint":118,"contacts":50},"Sinopharm Dongfeng General Hospital","Shiyan",{"type":106,"coordinates":115},[116,117],110.77806,32.6475,{"lat":117,"lon":116},{"facility":5,"status":50,"city":120,"state":102,"zip":50,"country":103,"countryCode":104,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Wuhan",{"type":106,"coordinates":122},[123,124],114.26667,30.58333,{"lat":124,"lon":123},[127,128],{"name":90,"role":91,"phone":92,"phoneExt":50,"email":93},{"name":95,"role":91,"phone":50,"phoneExt":50,"email":97},{"facility":130,"status":50,"city":120,"state":102,"zip":50,"country":103,"countryCode":104,"cosmosGeoPoint":131,"geoPoint":133,"contacts":50},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"type":106,"coordinates":132},[123,124],{"lat":124,"lon":123},{"facility":135,"status":50,"city":136,"state":102,"zip":50,"country":103,"countryCode":104,"cosmosGeoPoint":137,"geoPoint":141,"contacts":50},"Xiangyang No.1 People's Hospital","Xiangyang",{"type":106,"coordinates":138},[139,140],112.14479,32.0422,{"lat":140,"lon":139},{"type":87,"investigatorFullName":86,"investigatorTitle":143,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Professor","100639156",false,"NCT07611552","Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss","The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Medications for Weight Loss: a Randomized Double-blind Controlled Trial","Inclusion criteria:\n\n* Be overweight or obese (meeting any of the following criteria):\n\n  1. Obesity: BMI \\>=28 kg\u002Fm²;\n  2. Overweight (BMI \\>= 24 kg\u002Fm²) with at least one body weight-related comorbidity: obstructive sleep apnea syndrome, prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia, polycystic ovary syndrome, or non-alcoholic fatty liver disease.\n* Must have received GLP-1 RA drugs (Semaglutide, Liraglutide, Benaglutide, Tirzepatide, or Mazdutide) for weight-loss intervention for at least 3 months, and plan to continue using them for the next six months.\n* Age 18-64 years.\n* Consent to participate and sign the informed consent form.\n\nExclusion criteria:\n\n* Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo weight-loss procedures within the next 4 months;\n* Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt);\n* Be allergic or intolerance to inulin-type substances;\n* Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials;\n* Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding;\n* Deemed unsuitable for participation by the investigator's judgment.","ALL","18 Years","64 Years",{"count":154,"type":155},600,"ESTIMATED","INTERVENTIONAL",[158],"NA","The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications for weight loss.",[161],"Obesity & Overweight",[163,164,165,166,167],"weight loss","cardiometabolic risk factors","prebiotics","lipids","glucagon-like peptide-1 receptor agonists (GLP-1 RA)","NOT_YET_RECRUITING","2026-06-01",{"date":171,"type":172},"2026-06-03","ACTUAL",{"date":174,"type":155},"2026-06",{"date":176,"type":155},"2026-11",{"name":5,"class":6},5]