[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619383":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":35,"locations":43,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":12,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":12,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":108,"whyStopped":12,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Oklahoma","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control - no intervention","NO_INTERVENTION","This arm is the control arm that will not receive food-based dietary intervention",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Chia Seeds","EXPERIMENTAL","This group will receive the food-based intervention",[18],"Dietary Supplement: Chia seeds",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIETARY_SUPPLEMENT","Chia seeds","Chia seeds will be given to lactating mothers.",[14],[26,29,32],{"name":27,"affiliation":5,"role":28},"David A Fields, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Kathy Burge, PhD","University of Oklahoma Health Sciences",{"name":33,"affiliation":34,"role":28},"Paige H Berger, Phd, RDN","Brigham and Women's Hospital",[36,40],{"name":27,"role":37,"phone":38,"phoneExt":12,"email":39},"CONTACT","405-271-2767","david-fields@ou.edu",{"name":30,"role":37,"phone":41,"phoneExt":12,"email":42},"405-271-5215","kathryn-burge@ou.edu",[44,63],{"facility":45,"status":12,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Brigham and Womens Hospital","Boston","Massachusetts","02115","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":12,"email":61},"Paige K Berger, Phd, RDN","617-525-4131","pberger@bwh.harvard.edu",{"name":59,"role":28,"phone":12,"phoneExt":12,"email":12},{"facility":64,"status":12,"city":65,"state":66,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":52,"coordinates":69},[70,71],-97.51643,35.46756,{"lat":71,"lon":70},[74,76],{"name":27,"role":37,"phone":75,"phoneExt":12,"email":39},"405-271-3093",{"name":77,"role":28,"phone":12,"phoneExt":12,"email":12},"Kathy Burge, Phd",{"type":79,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[81,83],{"name":82,"class":6},"Presbyterian Health Foundation",{"name":34,"class":6},"100619383","impact-of-chia-seeds-on-human-breast-milk-composition-100619383",false,"NCT07343908","Impact of Chia Seeds on Human Breast Milk Composition","An RCT: Impact of Chia Seeds on Human Breast Milk Composition","Inclusion Criteria:\n\n* pre-pregnancy BMI \\>25 kg\u002Fm²\n* Maternal age 18 - 45 years at time of delivery\n* Singleton pregnancy\n* Vaginal delivery\n* Intention to breast feed for at least three months\n* No prescription medications that may interfere with gut microbiome\n* Not taking antibiotics for ≥ 1 week prior to each visit\n* No chia seed supplements during pregnancy\n\nExclusion Criteria:\n\n* Inability to understand English\n* Preterm or post-term birth (gestational age \\\u003C37 or \\>42 weeks)\n* Congenital or other defect or medical condition that would affect the mother's ability to produce milk or the infant's growth or ability to breastfeed\n* Infant eating more than 12 ounces of any liquid other than breast milk in the two weeks prior to each study visit\n* Taking Antibiotics (all), Proton pump inhibitors\u002FH2 blockers, Metformin, NSAIDs, Statins, SSRIs and tricyclic antidepressants","ALL","18 Years","45 Years",{"count":95,"type":96},80,"ESTIMATED","INTERVENTIONAL",[99],"NA","The investigators' over-arching hypothesis is that mechanical and compositional properties of chia seeds supplemented during lactation diminish obesity-induced intestinal inflammation and barrier dysfunction. The investigators hypothesize these changes will result in: 1) reduced maternal systemic inflammation (serum CRP and IL-6) and increased gut microbial diversity and richness, 2) reduced HM fat and inflammatory markers, metrics the research team have demonstrated differ in tandem with maternal metabolic health and 3) improved infant growth\u002Fbody composition. To test these hypotheses, investigators will evaluate chia seed supplementation during lactation in a 6wk multi-site pilot RCT (Aim 1) and through translational studies using human enteroids (Aim 2).",[102,103],"Obesity and Overweight","Breastfeeding, Exclusive",[102,103,105,106,107],"Breastmilk","Body Composition","Infant Growth","NOT_YET_RECRUITING","2026-05-14",{"date":111,"type":112},"2026-05-15","ACTUAL",{"date":114,"type":96},"2026-08",{"date":116,"type":96},"2027-12",{"name":5,"class":6},2]