[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637083":3},{"organization":4,"outcomesModule":7,"designInfo":87,"detailedDescription":97,"studyPopulation":11,"armGroups":98,"interventions":117,"overallOfficials":11,"centralContacts":135,"locations":142,"responsibleParty":165,"collaborators":167,"id":171,"slug":11,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":11,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":178,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":11,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":11,"overallStatus":144,"whyStopped":11,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Taipei Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48,50,52,54,56,58,60,63,65,67,69,71,73,76,78,80,82,84],{"measure":10,"description":11,"timeFrame":12},"Serum Ketone Bodies",null,"week0 and week8",{"measure":14,"description":11,"timeFrame":15},"Albumin","Week0 and week8",{"measure":17,"description":11,"timeFrame":12},"Aspartate Aminotransferase (AST)",{"measure":19,"description":11,"timeFrame":12},"Alanine Aminotransferase (ALT)",{"measure":21,"description":11,"timeFrame":12},"Gamma-Glutamyl Transferase (GGT)",{"measure":23,"description":11,"timeFrame":12},"Blood Creatinine",{"measure":25,"description":11,"timeFrame":12},"Blood Urea Nitrogen (BUN)",{"measure":27,"description":11,"timeFrame":12},"Uric Acid",{"measure":29,"description":11,"timeFrame":12},"Sodium (Na⁺)",{"measure":31,"description":11,"timeFrame":12},"Potassium (K⁺)",{"measure":33,"description":11,"timeFrame":12},"Free Fatty Acids (FFA)",{"measure":35,"description":11,"timeFrame":12},"Thyroid Stimulating Hormone (TSH)",{"measure":37,"description":11,"timeFrame":12},"white blood cell (WBC) count\u002Fautomated differential",{"measure":39,"description":11,"timeFrame":12},"red blood cell (RBC) count",{"measure":41,"description":11,"timeFrame":12},"hemoglobin",{"measure":43,"description":11,"timeFrame":12},"hematocrit",{"measure":45,"description":11,"timeFrame":12},"platelet count",{"measure":47,"description":11,"timeFrame":12},"mean corpuscular volume (M.C.V)",{"measure":49,"description":11,"timeFrame":12},"mean corpuscular hemoglobin concentration (M.C.H.C)",{"measure":51,"description":11,"timeFrame":12},"total cholesterol (TC)",{"measure":53,"description":11,"timeFrame":12},"high-density lipoprotein cholesterol (HDL-C)non-HDL-C",{"measure":55,"description":11,"timeFrame":12},"low-density lipoprotein cholesterol (LDL-C)",{"measure":57,"description":11,"timeFrame":12},"triglycerides (TG)",{"measure":59,"description":11,"timeFrame":12},"glucose AC",{"measure":61,"description":11,"timeFrame":62},"Height","week0 , week4 and week8",{"measure":64,"description":11,"timeFrame":62},"Weight",{"measure":66,"description":11,"timeFrame":62},"Body Mass Index (BMI)",{"measure":68,"description":11,"timeFrame":62},"Body Composition (muscle mass, fat mass, visceral fat level)",{"measure":70,"description":11,"timeFrame":62},"Hip Circumference",{"measure":72,"description":11,"timeFrame":62},"Waist-to-Hip Ratio (WHR)",{"measure":74,"description":11,"timeFrame":75},"Fecal Sample(Akkermansia muciniphila, qPCR (quantitative polymerase chain reaction))","week0, week8",{"measure":77,"description":11,"timeFrame":12},"Next-Generation Sequencing (NGS)",{"measure":79,"description":11,"timeFrame":12},"Urinalysis",{"measure":81,"description":11,"timeFrame":62},"Dietary Record",{"measure":83,"description":11,"timeFrame":62},"Bowel Movement Record",{"measure":85,"description":11,"timeFrame":86},"Gastrointestinal Questionnaire","Week0 , week4 and week8",{"allocation":88,"interventionModel":89,"interventionModelDescription":90,"primaryPurpose":91,"observationalModel":11,"timePerspective":11,"maskingInfo":92},"NON_RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of four groups: a high-dose intervention group, a low-dose intervention group, a high-dose placebo group, and a low-dose placebo group (35 participants per group).","TREATMENT",{"masking":93,"maskingDescription":11,"whoMasked":94},"DOUBLE",[95,96],"PARTICIPANT","INVESTIGATOR","All participants will undergo blood, urine, and fecal sample collection at baseline and after 8 weeks of supplementation. Body composition measurements and questionnaire assessments will be conducted at baseline, after 4 weeks, and after 8 weeks of supplementation. The collected data will be analyzed using a two-way mixed-design analysis of variance (ANOVA) to compare both between-group and within-group differences.",[99,104,108,113],{"label":100,"type":101,"description":11,"interventionNames":102},"high-dose intervention group","EXPERIMENTAL",[103],"Dietary Supplement: PI-YSP-0111 formulation (High-dose)",{"label":105,"type":101,"description":11,"interventionNames":106},"low-dose intervention group",[107],"Dietary Supplement: PI-YSP-0111 formulation (Low-dose)",{"label":109,"type":110,"description":11,"interventionNames":111},"high-dose placebo group","PLACEBO_COMPARATOR",[112],"Dietary Supplement: Placebo group(High-dose)",{"label":114,"type":110,"description":11,"interventionNames":115},"low-dose placebo group",[116],"Dietary Supplement: Placebo group(Low-dose)",[118,123,127,131],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":11},"DIETARY_SUPPLEMENT","PI-YSP-0111 formulation (High-dose)","6 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)",[100],{"type":119,"name":124,"description":125,"armGroupLabels":126,"otherNames":11},"PI-YSP-0111 formulation (Low-dose)","4 per day(Lactobacillus rhamnosus MB17, Lactobacillus plantarum MB-10, Grape Seed extract, Oligo, Wofberry Extract Powder, Maltose powder, Aerosil, Magnesium Stearate)",[105],{"type":119,"name":128,"description":129,"armGroupLabels":130,"otherNames":11},"Placebo group(High-dose)","6 per day(Maltose powder, Aerosil, Magnesium Stearate)",[109],{"type":119,"name":132,"description":133,"armGroupLabels":134,"otherNames":11},"Placebo group(Low-dose)","4 per day(Maltose powder, Aerosil, Magnesium Stearate)",[114],[136],{"name":137,"role":138,"phone":139,"phoneExt":140,"email":141},"Ming Ta Yang, Professor","CONTACT","+886-2-27361661","2275","yangrugby@tmu.edu.tw",[143,157],{"facility":5,"status":144,"city":145,"state":146,"zip":147,"country":146,"countryCode":148,"cosmosGeoPoint":149,"geoPoint":154,"contacts":155},"RECRUITING","Taipei","Taiwan","110","TW",{"type":150,"coordinates":151},"Point",[152,153],121.52639,25.05306,{"lat":153,"lon":152},[156],{"name":137,"role":138,"phone":139,"phoneExt":140,"email":141},{"facility":158,"status":144,"city":145,"state":146,"zip":159,"country":146,"countryCode":148,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Taipei Municipal WanFang Hospital(Managed by Taipei Medical University)","116",{"type":150,"coordinates":161},[152,153],{"lat":153,"lon":152},[164],{"name":137,"role":138,"phone":139,"phoneExt":140,"email":141},{"type":166,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[168],{"name":169,"class":170},"Yung Shin Pharm. Ind. Co., Ltd.","INDUSTRY","100637083",false,"NCT07618000","PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition","Evaluation of the Effects of the PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition","Inclusion Criteria:\n\n1. Healthy males or females aged 18 to 65 years.\n2. BMI between 23.0 and 40.0 kg\u002Fm².\n3. Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.\n4. Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate.\n5. Participants have fully understood the study procedures and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.\n2. Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (\\>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs \\[NSAIDs\\]).\n3. Exposure to unapproved medications, alcohol abuse, or substance abuse.\n4. Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded).\n5. Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.\n6. Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.\n7. Participation in any other interventional clinical study within the past one month.\n8. History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.\n9. Occurrence of major trauma or any surgical procedures within the past one month.\n10. History of diabetic ketoacidosis.",true,"ALL","18 Years","65 Years",{"count":182,"type":183},140,"ESTIMATED","INTERVENTIONAL",[186],"NA","The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.",[189],"Heathly Volunteers","2026-05-26",{"date":192,"type":193},"2026-06-01","ACTUAL",{"date":195,"type":193},"2026-04-08",{"date":197,"type":183},"2027-04-07",{"name":5,"class":6},2]