[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628121":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":28,"responsibleParty":85,"collaborators":88,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":104,"minAge":105,"maxAge":10,"enrollmentInfo":106,"targetDuration":10,"studyType":109,"phases":10,"briefSummary":110,"conditions":111,"keywords":126,"overallStatus":139,"whyStopped":10,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Warsaw University of Life Sciences","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Normal weight (NW)",null,"n=55 (maternal BMI at baseline 18.5-24.9 kg\u002Fm²)",{"label":13,"type":10,"description":14,"interventionNames":10},"Overweight (OW)","n=55 (maternal BMI at baseline 25-29.9 kg\u002Fm²)",{"label":16,"type":10,"description":17,"interventionNames":10},"Obesity (OB)","n=55 (maternal BMI at baseline \\>29.9 kg\u002Fm²)",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Monika A. Zielinska-Pukos, PhD","CONTACT","+48225937125","monika_zielinska_pukos@sggw.edu.pl",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Jadwiga Hamulka, Professor","+48225937122","jadwiga_hamulka@sggw.edu.pl",[29,42,54,64],{"facility":30,"status":10,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":10},"Food, Nutrition and Health, Uviversity of British Columbia; Affiliated Investigator, Healthy Starts, BC Children's Hospital Research Institute & Women's Health Research Institute","Vancouver","British Columbia","V6T 1Z4","Canada","CA",{"type":37,"coordinates":38},"Point",[39,40],-123.11934,49.24966,{"lat":40,"lon":39},{"facility":43,"status":10,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":53,"contacts":10},"Wroclaw Medical University","Wroclaw","Lower Silesian Voivodeship","50-367","Poland","PL",{"type":37,"coordinates":50},[51,52],17.03006,51.10286,{"lat":52,"lon":51},{"facility":55,"status":10,"city":56,"state":57,"zip":58,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":63,"contacts":10},"National Institute of Public Health NIH - National Research Institute","Warsaw","Masovian Voivodeship","00-791",{"type":37,"coordinates":60},[61,62],21.01178,52.22977,{"lat":62,"lon":61},{"facility":65,"status":10,"city":56,"state":57,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Department of Human Nutrition, Institute of Human Nutrition Sciences, Warsaw University of Life Sciences (SGGW-WULS)","02-776",{"type":37,"coordinates":68},[61,62],{"lat":62,"lon":61},[71,73,75,77,79,81,83],{"name":20,"role":72,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":25,"role":74,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":76,"role":74,"phone":10,"phoneExt":10,"email":10},"Malgorzata E. Drywien, PhD",{"name":78,"role":74,"phone":10,"phoneExt":10,"email":10},"Magdalena Gornicka, PhD",{"name":80,"role":74,"phone":10,"phoneExt":10,"email":10},"Marta Jeruszka-Bielak, PhD",{"name":82,"role":74,"phone":10,"phoneExt":10,"email":10},"Joanna Frackiewicz, PhD",{"name":84,"role":74,"phone":10,"phoneExt":10,"email":10},"Kacper Szewczyk, PhD",{"type":72,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Monika Zielinska-Pukos","Principal Investigator",[89,90,93],{"name":43,"class":6},{"name":91,"class":92},"National Science Centre, Poland","OTHER_GOV",{"name":94,"class":92},"National Institute of Public Health, National Research Institute, Poland","100628121","breastmilk-and-the-link-to-overweightobesity-and-maternal-diet-in-the-mother-breastmilk-child-triad-100628121",false,"NCT07457515","Breastmilk and the Link to Overweight\u002FObesity and Maternal Diet in the Mother-breastmilk-child Triad","Analysis of the Transmission of Overweight\u002FObesity in the Mother-breastmilk-child Triad in Relation to Maternal Cardiometabolic Status and Diet","BLOOM-Triad","Inclusion Criteria:\n\nfor mother:\n\n* at least 19 years,\n* plan of exclusively or predominantly breastfeeding for 6 months,\n* consent to a sampling of biological material and participate in all planned procedures (for both mother and infant),\n* willingness to finish the follow-up,\n* well-understanding of the Polish language (for non-Polish nationalities); for infants:\n* 1 month or less,\n* clinically healthy,\n* none or one formula feeding per day\n\nExclusion Criteria:\n\nfor mother:\n\n* type 1 or 2 diabetes diagnosed before pregnancy,\n* uncontrolled thyroid disease,\n* breastfeeding more than 1 child or being a milk donor,\n* tobacco\u002Falcohol use during pregnancy or currently,\n* inability to express a sufficient amount of milk; for infants:\n* congenital disease,\n* birth from a multiple pregnancy,\n* preterm birth (\\\u003C37 Hbd).",true,"FEMALE","19 Years",{"count":107,"type":108},165,"ESTIMATED","OBSERVATIONAL","The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity). The investigators plan 3 study visits (1, 3, and 6 months postpartum) with analysis the following parameters and outcomes:\n\n1. maternal anthropometry and body composition;\n2. maternal dietary intake and dietary patterns (with results of biomarker-based validation);\n3. maternal status of lipophilic antioxidants, selected vitamins, and fatty acids profile that may be related to adipose tissue metabolism, inflammation, and cardiometabolic status;\n4. maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation;\n5. breastmilk composition assessed by systemic approach (macronutrients, fatty acids profile, lipophilic antioxidants, adipokines, hormones, immunological profile, and preliminary lipidomic analysis in part of the study group);\n6. infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress.\n\nAdditionally, maternal and infant stool, buccal swabs, and human milk samples will be banked for further microbiome analysis studies.",[112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Body Weight","Obesity & Overweight","Human Milk\u002FBreastfeeding","Body Composition","Maternal Cardiometabolic Health","Growth & Development","Metabolomic Profile","Infant Body Composition and Metabolism","Carotenoid Status","Fatty Acid Status","Immunologic Markers","Adipokines","Inflammation Biomarkers","Vitamin E",[127,128,129,130,123,131,132,133,134,135,136,137,138],"Lactation","Body composition","Infant development","Diet","Carotenoids","Fatty acids","Metabolomics","Inflammation","Oxidative stress","Overweight","Obesity","Tocopherols","NOT_YET_RECRUITING","2026-03-02",{"date":142,"type":143},"2026-03-09","ACTUAL",{"date":145,"type":108},"2026-02",{"date":147,"type":108},"2029-09",{"name":5,"class":6},4]