[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626711":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":66,"collaborators":68,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":41,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":41,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":41,"overallStatus":97,"whyStopped":41,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Cornell University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Consumption of insect-fortified (crickets and black soldier fly larvae) crackers.",[13],"Dietary Supplement: Cricket and Black Soldier Fly Larvae-fortified Cracker",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Consumption of rice and corn crackers",[19],"Dietary Supplement: Rice and Corn Cracker",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Cricket and Black Soldier Fly Larvae-fortified Cracker","Children will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks.",[9],[27],"Treatment Cracker",{"type":22,"name":29,"description":24,"armGroupLabels":30,"otherNames":31},"Rice and Corn Cracker",[15],[32],"Control Cracker",[34],{"name":35,"affiliation":5,"role":36},"John Hoddinott, DPhil","STUDY_CHAIR",[38,43],{"name":35,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","240-447-0918",null,"jfh246@cornell.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Megan Parker, PhD","202-460-6239","mparker@path.org",[48],{"facility":49,"status":41,"city":50,"state":51,"zip":41,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"FSRP Sschools","Antsirabe","Vakinankaratra Region","Madagascar","MG",{"type":55,"coordinates":56},"Point",[57,58],47.03333,-19.86586,{"lat":58,"lon":57},[61,63,64],{"name":62,"role":39,"phone":40,"phoneExt":41,"email":42},"John Hoddinott, PhD",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},{"name":35,"role":65,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[69,71,73],{"name":70,"class":6},"PATH",{"name":72,"class":6},"Institut Pasteur de Madagascar",{"name":74,"class":75},"Université d'Antananarivo","UNKNOWN","100626711","impact-of-a-cricket-and-black-soldier-fly-larvae-fortified-cracker-on-the-gut-microbiome-and-iron-status-in-malagasy-schoolchildren-100626711",false,"NCT07439185","Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren","Inclusion criteria for children\n\n* Child (male, female, intersex, non-binary), aged 9 to 13 years old who attends one of the selected schools\n* Caregiver or legal guardian is willing to provide informed consent\n* Child is willing to provide informed assent\n\nExclusion criteria for children\n\n* Child age is outside the preferred age range (9 to 13 years)\n* Not enrolled in the participating schools\n* Unable or unwilling to comply with the study requirements\n* Illness requiring medical treatment, malaria, severe anemia (hemoglobin (Hb) concentration below 8.0 g\u002FdL as indicated by HemoCue 201+ system), severe acute malnutrition, fever, diarrhea, etc.\n* Covid-exposure or symptoms: loss of smell or taste\n* History of food allergies or adverse reactions to any edible insects\n* Chronic severe medical condition or congenital anomalies requiring frequent medical attention or interfering with dietary consumption\n* Caregiver does not give consent, or child does not assent\n\nInclusion criteria for parents • Willing to participate in completing surveys about demographics and household dynamics (assets, housing structure, etc.)\n\nExclusion criteria for parents\n\n• Caregiver does not consent to participate",true,"ALL","9 Years","13 Years",{"count":87,"type":88},650,"ESTIMATED","INTERVENTIONAL",[91],"NA","The purpose of this study is to determine the health impacts of consistent consumption of insect-fortified crackers among school-aged children in Madagascar.\n\nSpecifically, in this RCT, the investigators will assess whether the insect-fortified crackers can improve the health status of Malagasy school children. The investigators' objectives are to: (1) Assess changes in gut microbiome composition that occur after 6 and 14 weeks of cracker consumption through 16S rRNA sequencing. (2) Assess changes in intestinal and systemic inflammation after 6 and 14 weeks of cracker consumption through quantification of fecal calprotectin, lactoferrin, myeloperoxidase (MPO), and alpha-1-antitrypsin (AAT) and circulating pro-inflammatory cytokines. (3) Assess changes in iron status after 14 weeks of cracker consumption through quantification of hemoglobin (Hb), inflammation-adjusted serum ferritin, and soluble transferrin receptor (sTfR).",[94,95,96],"Gut -Microbiota","Inflamation","Iron Absorption","NOT_YET_RECRUITING","2026-02-23",{"date":100,"type":101},"2026-02-27","ACTUAL",{"date":103,"type":88},"2026-02",{"date":105,"type":88},"2026-06",{"name":5,"class":6},1]