[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621651":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":63,"collaborators":67,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":31,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":31,"enrollmentInfo":81,"targetDuration":31,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":105,"whyStopped":31,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Aalborg University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LP-LDL® (Active Treatment)","ACTIVE_COMPARATOR","Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks",[13],"Dietary Supplement: Lactobacillus plantarum ECGC 13110402",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks",[19],"Dietary Supplement: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Lactobacillus plantarum ECGC 13110402","LP-LDL® (Lactobacillus plantarum ECGC 13110402) is a probiotic dietary supplement provided in a capsule containing a minimum of 4 × 10⁹ CFU of the viable bacterial strain at the time of release. Each active capsule contains 50 mg of freeze-dried Lactobacillus plantarum ECGC 13110402, blended with 165 mg of corn starch and 25 mg of microcrystalline cellulose as excipients. Participants assigned to the active arm will take one capsule orally once daily for 12 weeks.",[9],[27],"LP-LDL",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The placebo consists of an identical capsule containing only the excipients (215 mg corn starch and 25 mg microcrystalline cellulose) without any live bacteria. Active and placebo capsules are identical in appearance, packaging, labeling, and handling to maintain blinding. All products are manufactured, blended, encapsulated, blind-labeled, and packaged under GMP conditions by ProBiotix Health.",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Peter Vestergaard (PI), Chair Professor, Dr Med, PhD","CONTACT","+45 97663673","p.vestergaard@rn.dk",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Hiva Alipour, DVM, PhD","+45 99403807","hiva@hst.aau.dk",[43,55],{"facility":44,"status":31,"city":45,"state":31,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":31},"Department of Health Science and Technology, Aalborg University","Gistrup","9260","Denmark","DK",{"type":50,"coordinates":51},"Point",[52,53],9.99085,56.9943,{"lat":53,"lon":52},{"facility":56,"status":31,"city":45,"state":31,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Steno Diabetes Center Nordjylland",{"type":50,"coordinates":58},[52,53],{"lat":53,"lon":52},[61],{"name":62,"role":35,"phone":36,"phoneExt":31,"email":37},"Peter Vestergaard, MD, PhD",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Hiva Alipour","Associate Professor, Department of Health Science and Technology",[68,69],{"name":56,"class":6},{"name":70,"class":71},"ProBiotix Health Plc.","UNKNOWN","100621651","effects-of-lp-ldl-on-lipid-metabolism-glycemic-control-inflammatory-markers-and-cognitive-function-in-individuals-with-prediabetes-and-diabetes-mellitus-100621651",false,"NCT07373392","Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus","Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus (Type 1 and Type 2)","Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Prediabetes (FPG 100-125 mg\u002FdL or HbA1c 42-47 mmol\u002Fmol), or Type 1 or Type 2 diabetes\n* Elevated cholesterol or triglycerides (TC ≥200 mg\u002FdL, LDL 130-189 mg\u002FdL, or TG \\>150 mg\u002FdL)\n* Either no lipid-lowering medication or stable dose for ≥4 weeks\n* Able to swallow capsules and understand Danish\n* Willing to maintain lifestyle habits and provide stool and blood samples\n\nExclusion Criteria:\n\n* Antibiotic use in the past 3 months\n* Severe dyslipidemia (\\>500 mg\u002FdL triglycerides)\n* Significant liver, kidney, thyroid disease\n* Pregnancy or breastfeeding\n* GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)\n* Long-term medications influencing lipid\u002Fglucose metabolism (except approved antidiabetic medications)\n* Participation in another trial within 3 months\n* Capsule intake \\\u003C80%","ALL","18 Years",{"count":82,"type":83},210,"ESTIMATED","INTERVENTIONAL",[86],"NA","This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels.\n\nA total of 210 participants will be enrolled across three parallel sub-studies:\n\n* Type 1 diabetes (n = 76)\n* Type 2 diabetes (n = 54)\n* Prediabetes (n = 80)\n\nParticipants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat).\n\nExploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5\u002FABCG8.\n\nThe study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.",[89,90,91],"Diabete Type 1","Diabete Type 2","Prediabetes",[91,93,94,95,96,97,98,99,27,100,23,101,102,103,104],"Type 1 Diabetes","Type 2 Diabetes","Dyslipidemia","Hypercholesterolemia","Metabolic dysfunction","Insulin resistance","Probiotics","Lactobacillus plantarum","Dietary supplement","Microbiome modulation","LDL cholesterol","Cardiometabolic health","NOT_YET_RECRUITING","2026-01-27",{"date":108,"type":109},"2026-01-29","ACTUAL",{"date":111,"type":83},"2026-01-25",{"date":113,"type":83},"2028-09-01",{"name":5,"class":6},2]