[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523157":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":41,"responsibleParty":60,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":105,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active multi-ingredient supplement (Fertility Enhancer; FE)","EXPERIMENTAL","Volunteers will be randomized in a double-blinded fashion into the experimental treatment group, which entails daily supplementation of an active multi-ingredient supplement designed to enhance fertility (Fertility Enhancer; FE) for 3 months.",[13],"Dietary Supplement: Active multi-ingredient supplement (Fertility Enhancer, FE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Inactive placebo (Placebo; PLA)","PLACEBO_COMPARATOR","Volunteers will be randomized in a double-blinded fashion into a placebo group, which entails daily supplementation of a calorie-matched, inactive placebo (Placebo; PLA) identical in flavor to the active supplement for 3 months.",[19],"Dietary Supplement: Inactive placebo (Placebo; PLA)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Active multi-ingredient supplement (Fertility Enhancer, FE)","Consuming a multi-ingredient supplement targeting multiple cell pathways daily for 3 months.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Consuming an inactive placebo that is calorie-matched to the active supplement daily for 3 months.",[15],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Mark A Tarnopolsky, PhD","CONTACT","9055212100","76593","tarnopol@mcmaster.ca",{"name":38,"role":33,"phone":34,"phoneExt":39,"email":40},"Mats Nilsson","76680","mats.nilsson@exerkine.com",[42],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Mark Tarnopololsky","Hamilton","Ontario","L8N 3Z5","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-79.84963,43.25011,{"lat":53,"lon":52},[56,58],{"name":32,"role":33,"phone":57,"phoneExt":35,"email":36},"905-525-2100",{"name":59,"role":33,"phone":57,"phoneExt":39,"email":40},"Mats I Nilsson, PhD",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mark Tarnopolsky","Professor",[65],{"name":66,"class":6},"One Fertility","100523157","phase-2-supplementation-for-male-subfertility-100523157",false,"NCT06091969","Supplementation for Male Subfertility","Nutraceutical Supplementation for Male Subfertility","FertEnhancer","Inclusion Criteria:\n\n* Males between the ages of 25-50 years diagnosed with subfertility through Ontario Networks of Experts in Fertility (ONE Fertility, Burlington, ON).\n* For diagnosis of male subfertility, the 2010 and 2021 World Health Organization criteria will be used for sperm count, motility, morphology and vitality.\n* Overweight and obese males according to body mass index (BMI) between the ages of 25-50 years.\n\nExclusion Criteria:\n\n* Smoking,\n* history and drug alcohol abuse,\n* BMI \\> 30 kg\u002Fm2,\n* genital disease (cryptorchidism, current genital inflammation, or varicocele),\n* genital trauma or surgery to the male reproductive system,\n* known Y chromosome microdeletions or karyotype abnormalities (if known prior),\n* hepatobiliary disease,\n* significant renal insufficiency,\n* occupational exposures to reproductive toxins,\n* endocrine abnormality,\n* recent or current sexually transmitted infection,\n* use of cytotoxic drugs,\n* use of immunosuppressants,\n* use of anticonvulsants,\n* use of androgens or antiandrogens,\n* history of central nervous system injury,\n* neurological or psychiatric disease to potentially compromise study data collection,\n* treatment of erectile dysfunction with any drugs during the past 4 weeks,\n* history of cancer chemotherapy,\n* current supplementation with ingredients being tested unless 1-month washout period",true,"MALE","25 Years","50 Years",{"count":80,"type":81},64,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","Old age, obesity, physical inactivity, environmental factors and genetics may contribute negatively to fertility in both males and females. In males, specifically, certain supplements, such as single antioxidants and trace minerals, have previously been shown to improve sperm function marginally. One hypothesis is that sperm function can be improved even further by combining several different types of supplements (e.g., amino acids, energy carriers, vitamins, antioxidants, and trace minerals) to target several age-related cell pathways, for example, oxidative stress, mitochondrial dysfunction, inflammation and cell energetics. This 3-month placebo-controlled, randomized clinical trial, aims to test the effects of a novel multi-ingredient supplement (Fertility Enhancer) that targets several age-related cell pathways on sperm function in overweight or obese and subfertile males.",[87],"Male Infertility",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"Sub-fertility","Infertility","Antioxidants","Supplements","Creatine","Arginine","Vitamins","Aging","Oxidative stress","Inflammation","DNA","Mitochondria","Fragmentation","ATP","Weight loss","Obesity","NOT_YET_RECRUITING","2024-10-08",{"date":108,"type":109},"2024-10-10","ACTUAL",{"date":111,"type":81},"2025-01-01",{"date":113,"type":81},"2026-02-02",{"name":115,"class":6},"Hamilton Health Sciences Corporation",1]