[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644389":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Shanghai 10th People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Trial group (spermidine)","EXPERIMENTAL","Spermidine capsules 10 mg\u002Fday",[13],"Drug: Spermidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group (placebo)","PLACEBO_COMPARATOR","Placebo 10 mg\u002Fday",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Spermidine","Spermidine (10 mg\u002Fday) administered as two oral capsules taken after breakfast. The spermidine is extracted from North American high-selenium wheat germ using a 100:1 concentration process. Each capsule contains 5 mg of spermidine, with a total daily dose of 10 mg. The intervention duration is 1 month.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo capsules are identical in appearance, color, size, packaging, and taste to the spermidine capsules. Each capsule is filled with microcrystalline cellulose and contains no active ingredients. Participants will take two placebo capsules orally after breakfast daily for a duration of 1 month. The placebo is packaged and blinded by an independent pharmacy according to a randomization code to ensure double-blind implementation.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bu Le","CONTACT","+86 17701621016","geyingjun@hotmail.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Shanghai Tenth People'S Hospital","RECRUITING","Shanghai","Shanghai Municipality","200072","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Zhang Manna","Director, principal investigator, clinical professor","100644389","assessment-of-the-effects-and-safety-of-spermidine-supplementation-on-blood-lipids-and-body-weight-in-overweight-or-obese-individuals-with-hyperlipidemia-100644389",false,"NCT07662330","Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia","Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Males or females aged 18 to 65 years.\n* BMI ≥ 24 kg\u002Fm², without severe chronic diseases.\n* Not currently using glucose-lowering or lipid-lowering medications.\n* Dyslipidemia defined as triglycerides ≥ 1.7 mmol\u002FL or total cholesterol ≥ 5.2 mmol\u002FL.\n* No active weight loss or weight gain diet within the past 1 month.\n* No special dietary pattern changes (e.g., ketogenic, vegan, high-protein, meal replacement, intermittent fasting) within the past 1 month.\n* No use of supplements that may affect polyamine intake (e.g., germ, yeast, fermented extracts, nutritional powders) within the past 2-4 weeks.\n* Willing and able to provide signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of acute or severe gastrointestinal disease\n* Concurrent participation in any other weight-loss therapy\n* Current use of hypoglycemic or lipid-lowering medications\n* Participation in any other clinical trial within one month prior to signing the informed consent form\n* Pregnancy, lactation, or planning a pregnancy during the trial period\n* Known allergy to cellulose or wheat\n* History of cancer\n* Renal insufficiency, indicated by abnormal serum creatinine levels\n* Hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 × upper limit of normal (ULN), or total bilirubin (TBIL) \\>3 × ULN\n* Any other condition deemed by the investigator as inappropriate for trial participation","ALL","18 Years","60 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"NA","Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal reactions, and other adverse effects.",[76,77],"Obesity & Overweight","Hyperlipidemia","2026-06-22",{"date":80,"type":81},"2026-06-23","ACTUAL",{"date":83,"type":81},"2026-01-01",{"date":85,"type":70},"2027-01-31",{"name":5,"class":6},1]