[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483721":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":71,"collaborators":74,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":21,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":43,"whyStopped":21,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Umeå University","OTHER",[8,14,17,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Study formula 1","EXPERIMENTAL","Formula-fed intervention group randomised to one of two study formulae",[13],"Dietary Supplement: Partially hydrolysed formula",{"label":15,"type":10,"description":11,"interventionNames":16},"Study formula 2",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Standard formula","NO_INTERVENTION","Formula-fed control group randomised to standard formula",null,{"label":23,"type":19,"description":24,"interventionNames":21},"Breast feeding","Reference group with exclusively breast-fed infants",[26],{"type":27,"name":28,"description":28,"armGroupLabels":29,"otherNames":21},"DIETARY_SUPPLEMENT","Partially hydrolysed formula",[9,15],[31],{"name":32,"affiliation":33,"role":34},"Magnus Domellöf, MD, PhD","Department of Clinical Sciences, Pediatrics, Umeå University Hospital","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":21,"email":39},"CONTACT","+46907852128","magnus.domellof@umu.se",[41,59],{"facility":42,"status":43,"city":44,"state":21,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of clinical science, Preventive Paediatrics, Lund university","RECRUITING","Malmö","20502","Sweden","SE",{"type":49,"coordinates":50},"Point",[51,52],13.00073,55.60587,{"lat":52,"lon":51},[55,58],{"name":56,"role":37,"phone":21,"phoneExt":21,"email":57},"Pia Karlsland-Akeson, MD, PhD","pia.karlsland_akeson@med.lu.se",{"name":56,"role":34,"phone":21,"phoneExt":21,"email":21},{"facility":33,"status":43,"city":60,"state":21,"zip":61,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Umeå","901 85",{"type":49,"coordinates":63},[64,65],20.25972,63.82842,{"lat":65,"lon":64},[68,70],{"name":32,"role":37,"phone":69,"phoneExt":21,"email":39},"0046 90 7852128",{"name":32,"role":34,"phone":21,"phoneExt":21,"email":21},{"type":34,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Magnus Domellöf","Professor",[75,77],{"name":76,"class":6},"Lund University",{"name":78,"class":79},"Arla Foods","INDUSTRY","100483721","growth-allergy-and-neurodevelopment-in-infants-on-hydrolysed-formula-100483721",false,"NCT05578716","Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula","GRANDIOSA - Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula","GRANDIOSA","Inclusion Criteria:\n\n* Healthy infants born at term\n* Birth weight 2500 to 4500 gram\n* Either exclusive breast-feeding (reference group) or exclusive formula-feeding (intervention and control group)\n\nExclusion Criteria:\n\n* Suspected or verified food allergy\n* Suspected or verified infant colic",true,"ALL","4 Weeks","8 Weeks",{"count":93,"type":94},312,"ESTIMATED","INTERVENTIONAL",[97],"NA","Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants.\n\nProtein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants.\n\nNew protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk.\n\nThe overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.",[100],"Infant Formula",[102,103,104,105,106],"Infant nutrition","Food hypersensitivity","Dermatitis, Atopic","Protein hydrolysates","Spectroscopy, Near-Infrared","2023-12-11",{"date":109,"type":110},"2023-12-12","ACTUAL",{"date":112,"type":110},"2022-10-03",{"date":114,"type":94},"2026-06",{"name":5,"class":6},2]