[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598614":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Leeds Beckett University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group receiving the Lab4P probiotic capsules","EXPERIMENTAL","Experimental group will consume oral dose of 50 billion Colony forming Units (CFU) once daily till delivery.",[13],"Dietary Supplement: Lab4p Probiotic Consortium",{"label":15,"type":16,"description":17,"interventionNames":18},"Group receiving the identical, non-active placebo","PLACEBO_COMPARATOR","Microcrystalline cellulose\u002Fd each, up till delivery",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Lab4p Probiotic Consortium","The investigational product in this study is Lab4P, a patented multi-strain probiotic consortium formulated as a food supplement and supplied in capsule form. Each daily dose contains a total of 5 × 10¹⁰ CFU of live bacteria, comprising five strains: Lactobacillus acidophilus CUL60 and CUL21, Lactobacillus plantarum CUL66, Bifidobacterium bifidum CUL20, and Bifidobacterium animalis subsp. lactis CUL34. In addition to probiotics, each capsule also contains three micronutrients at 100-200% of the recommended daily intake: Vitamin D (10 µg; 200%), Vitamin C (80 mg; 100%), and Zinc (10 mg; 100%).\n\nLab4P is a marketed, human-approved product manufactured by Cultech Ltd. (Port Talbot, UK) and is classified as a food supplement, available for purchase without prescription. Both the active product and placebo will be identically packaged to maintain blinding.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo capsules are composed of microcrystalline cellulose, and are identical in appearance to the test product.",[15],[32,35,38],{"name":33,"affiliation":5,"role":34},"Lewis F Hepburn, Msc","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Lauren Owen, PhD","STUDY_CHAIR",{"name":39,"affiliation":5,"role":37},"Steve Trangmar, PhD",[41],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Lewis F Hepburn","CONTACT","+447541333140","l.hepburn3449@student.leedsbeckett.ac.uk",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Leeds","Greater Manchester","LS1 3HE","United Kingdom","UK",{"type":55,"coordinates":56},"Point",[57,58],-1.54785,53.79648,{"lat":58,"lon":57},[61,63],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":62},"L.hepburn3449@student.leedsbeckett.ac.uk",{"name":42,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lewis Hepburn","Principal Investigator",[68],{"name":69,"class":70},"Cultech Ltd, Port Talbot, UK","UNKNOWN","100598614","probiotic-impact-on-cognitive-performance-and-metabolic-outcomes-in-overweight-young-adults-with-impaired-glucose-regulation-100598614",false,"NCT07073781","Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation","A Double-blind Placebo-controlled Exploratory Trial to Assess the Impact of Daily Lab4P Probiotic Supplementation on Cognitive Performance and Metabolic Regulation in Overweight Young Adults With Impaired Glucose Regulation","ProCog","Inclusion Criteria\n\n* Aged 18-40 years\n* Body Mass Index (BMI) between 25.0 and 29.9 kg\u002Fm² (classified as overweight)\n* In good general health (self-reported)\n* Normal self-reported sleep patterns, with no history of diagnosed sleep disorders\n* Willing and able to provide informed consent\n* Able to comply with study procedures, including fasting and oral glucose tolerance testing\n\nExclusion Criteria:\n\n* Diagnosed diabetes (any type).\n* Diagnosed sleep disorders.\n* Fasting glucose \\>6.9 mmol\u002FL during screening.\n* History of bariatric surgery (e.g., gastric bypass, sleeve gastrectomy).\n* Major surgery, significant illness, trauma, infection, or myocardial infarction within the past 6 weeks.\n* Current use of medications affecting glucose metabolism or probiotics\n* Pregnancy or actively trying to conceive\n* Night shift work within the past month","ALL","18 Years","40 Years",{"count":83,"type":84},70,"ESTIMATED","INTERVENTIONAL",[87],"NA","This 12-week, double-blind, placebo-controlled trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight adults aged 18 to 40 with impaired glucose tolerance, a preclinical condition where blood glucose regulation is mildly disrupted. Seventy participants will be randomly assigned to receive either Lab4P or a placebo. The study will assess changes in memory, executive function, and processing speed, along with blood glucose control, cardiovascular function, cholesterol levels, body composition, and markers of inflammation. The study will also analyse changes in the gut microbiome and evaluate the safety and tolerability of the probiotic.",[90,91,92,93,94,95],"Impaired Glucose Regulation","Impaired Glucose Tolerance (Prediabetes)","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Overweight (BMI > 25)","Cognitive Dysfunction","Neurovascular Coupling Mechanism and Cognitive Function",[97,98,99,100,101,102],"Probiotic supplementation","Psychobiotic","Cognitive performance","Metabolic function","Impaired glucose tolerance","Gut-brain axis","2026-03-25",{"date":105,"type":106},"2026-03-31","ACTUAL",{"date":108,"type":106},"2025-08-15",{"date":110,"type":84},"2026-08-20",{"name":5,"class":6},1]