[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07343908":3,"trial-entities:NCT07343908":122,"trial-summary:NCT07343908":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":71,"locations":73,"central_contacts":106,"overall_officials":113,"references":120,"see_also_links":121},"NCT07343908","Chia Impact","Impact of Chia Seeds on Human Breast Milk Composition","An RCT: Impact of Chia Seeds on Human Breast Milk Composition","NOT_YET_RECRUITING","2027-12","2026-05","2026-05-15","2026-08","University of Oklahoma","OTHER",false,"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).","Childhood metabolic disease has become a progressively serious global health challenge. The investigators' preliminary data reveal maternal metabolic dysfunction and poor diet are associated with increased human milk fat, proinflammatory markers, and altered microbiota, potentially contributing to transmission of metabolic susceptibility to offspring, while their studies in animal models demonstrate associations between milk composition and offspring metabolic health may be a mechanism by which lactational programming dictates offspring metabolic susceptibility. The investigators' long-term goal is to identify easy-to-implement maternal dietary interventions to optimize offspring development and prevent childhood metabolic disease. Chia seeds contain fiber, polyphenols, -3 polyunsaturated fatty acids, and bioactive peptides, and, through a multitude of mechanisms, improve the metabolic health of those with type 2 diabetes and obesity. This project will test the hypotheses that (Aim 1) 6wks of chia seed supplementation will impact obese, lactating mothers' metabolic health, milk composition, and infant growth, and (Aim 2) chia seed polyphenols and bioactive peptides will reduce permeability, inflammation, and oxidative stress, as well as ATP generating metabolism, in human enteroids, at homeostasis and during in vitro lipotoxicity. Further, investigators will utilize a luciferase-reporter assay to evaluate whether chia seed bioactives function via activation of extraoral bitter taste receptors. Successful completion of this project will inform future maternal lactational interventions that are practical and effective in reducing offspring susceptibility to childhood obesity and diabetes, supporting feasibility for a multidisciplinary, collaborative grant focused on the metabolic health of mother-infant dyads.",[19,20],"Obesity and Overweight","Breastfeeding, Exclusive",[19,20,22,23,24],"Breastmilk","Body Composition","Infant Growth","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[28],"NA",{"count":30,"type":31},80,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIETARY_SUPPLEMENT","Chia seeds","Chia seeds will be given to lactating mothers.",[38],"Chia Seeds",[40,44],{"measure":41,"description":42,"timeFrame":43},"Breast milk","Breast milk composition primarily macronutrient composition (total fat, total carbohydrate, total protein along with caloric density). Additionally, markers of inflammation (IL-6 and CRP) along with metabolic health (glucose and insulin) will be measured in milk from the collection of a complete breast expression (\\~1 to 2 ounces).","6 weeks",{"measure":45,"description":46,"timeFrame":43},"Breast Milk","Changes in breast milk will be investigated (both macro nutrients and small bioactive). Macronutrient composition will encompass total fat, protein and carbohydrate, along with caloric density. Small bioactives will include glucose, insulin, CRP and IL-6. This will be measured by collecting breast milk from a complete breast expression (\\~1 to 2 ounces).",[48],{"measure":49,"description":50,"timeFrame":43},"Maternal serum levels following 6 week Chia seed intervention","Baseline and 6 weeks post intervention maternal serum (\\~5 ml) will be collected. Maternal serum will be measured for lipids (cholesterol, triglycerides, HDL, LDL) along with markers of inflammation (IL-6 and CRP) and metabolic health (insulin and glucose).","ALL","18 Years","45 Years",{"inclusion":55,"exclusion":64,"raw_text":70},[56,57,58,59,60,61,62,63],"pre-pregnancy BMI \\>25 kg\u002Fm²","Maternal age 18 - 45 years at time of delivery","Singleton pregnancy","Vaginal delivery","Intention to breast feed for at least three months","No prescription medications that may interfere with gut microbiome","Not taking antibiotics for ≥ 1 week prior to each visit","No chia seed supplements during pregnancy",[65,66,67,68,69],"Inability to understand English","Preterm or post-term birth (gestational age \\\u003C37 or \\>42 weeks)","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","Infant eating more than 12 ounces of any liquid other than breast milk in the two weeks prior to each study visit","Taking Antibiotics (all), Proton pump inhibitors\u002FH2 blockers, Metformin, NSAIDs, Statins, SSRIs and tricyclic antidepressants","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",[72],"ADULT",[74,91],{"facility":75,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":88},"Brigham and Womens Hospital","Boston","Massachusetts","02115","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Paige K Berger, Phd, RDN","CONTACT","617-525-4131","pberger@bwh.harvard.edu",{"name":82,"role":87},"PRINCIPAL_INVESTIGATOR",{"lat":89,"lon":90},42.35843,-71.05977,{"facility":92,"city":93,"state":94,"zip":95,"country":79,"contacts":96,"geoPoint":103},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",[97,101],{"name":98,"role":83,"phone":99,"email":100},"David A Fields, PhD","405-271-3093","david-fields@ou.edu",{"name":102,"role":87},"Kathy Burge, Phd",{"lat":104,"lon":105},35.46756,-97.51643,[107,109],{"name":98,"role":83,"phone":108,"email":100},"405-271-2767",{"name":110,"role":83,"phone":111,"email":112},"Kathy Burge, PhD","405-271-5215","kathryn-burge@ou.edu",[114,115,117],{"name":98,"affiliation":13,"role":87},{"name":110,"affiliation":116,"role":87},"University of Oklahoma Health Sciences",{"name":118,"affiliation":119,"role":87},"Paige H Berger, Phd, RDN","Brigham and Women's Hospital",[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Obesity",[],{"nct_id":4,"found":127,"summary":128,"prompt_version":138},true,{"design":129,"status":130,"heading":131,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is an interventional study planning to enroll 80 participants. It is a pilot randomized controlled trial (RCT) at multiple sites.","completed","Chia Seeds and Breast Milk Composition in Overweight\u002FObese Mothers","This study is looking at how eating chia seeds might affect breast milk and the health of both mothers and their babies. Researchers want to see if chia seeds can reduce inflammation (swelling) in mothers who are overweight or obese, and if this changes the fat and inflammatory markers in their breast milk. They also hope to see improved growth and body composition in the babies. You might be able to join if you are a mother between 18 and 45 years old, had a vaginal delivery, plan to breastfeed for at least three months, and had a pre-pregnancy BMI (Body Mass Index) over 25 kg\u002Fm². The study will measure breast milk composition at 6 weeks to see if the chia seeds have an impact. The current recruitment status is unclear.","Breast milk is measured at 6 weeks, which is the primary endpoint for the study.",131,"You would take chia seeds as a dietary supplement for 6 weeks. Breast milk will be measured at 6 weeks.","Not stated in the trial record.",[35],"v2"]