[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-formula\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-formula":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100505978","effect-of-partially-hydrolyzed-whey-based-infant-formulas-on-growth-and-tolerability-in-healthy-term-infants-100505978",false,"NCT05868408","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\]), if applicable)\n2. Infant gestational age ≥37 completed weeks\n3. Infant birth weight of ≥2.5 kg and ≤4.5 kg\n4. Singleton birth\n5. Infant postnatal age ≤28 days (date of birth = day 0)\n6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk\n7. Infant's parent(s)\u002FLAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth\n2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)\n3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)\n4. Infants with special dietary needs other than standard infant formula\n5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance\u002Fallergy, or lactose intolerance or severe food allergies that impact diet\n6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n7. Currently participating or having participated in another interventional clinical trial prior to enrollment",true,"ALL","0 Days","28 Days",{"count":21,"type":22},234,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.",[28,29,30,31,32],"Infant Nutritional Physiological Phenomena","Infant Formula","Infant Health","Infant Development","Growth and Development","RECRUITING","2025-12-18",{"date":36,"type":37},"2025-12-19","ACTUAL",{"date":39,"type":37},"2023-08-17",{"date":41,"type":22},"2028-06",{"name":43,"class":44},"Société des Produits Nestlé (SPN)","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100600324","studying-phenotypic-risks-for-obesity-and-underlying-traits-in-young-infants-100600324","NCT07096011","Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants","Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants: A Pilot Study","SPROUT","Inclusion Criteria:\n\n* Aged 2 weeks to less than 17 weeks at screening\n* Being fed human milk as a primary source of food\n* Be willing to consume one meal of infant formula\n* Be willing to complete a DXA measurement\n\nExclusion Criteria:\n\n* Unable to complete the screening visit and two clinic visits within 14 days\n* Born with health conditions that would render procedures unsafe\n* Born earlier than 35 days and 0 weeks gestation\n* Eating supplemental foods\n* Physician diagnosed feeding difficulties that may require a special type of nipple for bottle feeding","2 Weeks","16 Weeks",{"count":56,"type":22},40,"OBSERVATIONAL","The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes. The phenotypes are the 1) metabolic \"thriftiness\" and 2) the metabolic flexibility.",[60,61,62,29,63,64],"Infant Body Composition and Metabolism","Metabolism","Energy Expenditure","Human Milk, Breast Milk","Metabolic Flexibility",[66,67,68,69,70,71,72,73],"infant","metabolism","energy expenditure","infant formula","breast milk","human milk","thrifty phenotype","metabolic flexibility","2025-08-21",{"date":76,"type":37},"2025-08-22",{"date":78,"type":37},"2025-07-28",{"date":80,"type":22},"2027-05",{"name":82,"class":83},"Pennington Biomedical Research Center","OTHER",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":16,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100483721","growth-allergy-and-neurodevelopment-in-infants-on-hydrolysed-formula-100483721","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","4 Weeks","8 Weeks",{"count":96,"type":22},312,[25],"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.",[29],[101,102,103,104,105],"Infant nutrition","Food hypersensitivity","Dermatitis, Atopic","Protein hydrolysates","Spectroscopy, Near-Infrared","2023-12-11",{"date":108,"type":37},"2023-12-12",{"date":110,"type":37},"2022-10-03",{"date":112,"type":22},"2026-06",{"name":114,"class":83},"Umeå University",2]