Impact of Chia Seeds on Human Breast Milk Composition

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/body 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).

NCT Number	NCT07343908
Lead Sponsor	University of Oklahoma Collaborators: Presbyterian Health Foundation, Brigham and Women's Hospital
Conditions	Obesity and Overweight, Breastfeeding, Exclusive
Enrollment	80 participants
Start Date	2026-08
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-15