Impact of Chia Seeds on Human Breast Milk Composition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Oklahoma
About this trial
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).
Eligibility criteria
Qualifiers
pre-pregnancy BMI >25 kg/m²
Maternal age 18 - 45 years at time of delivery
Singleton pregnancy
Vaginal delivery
Disqualifiers
Inability to understand English
Preterm or post-term birth (gestational age <37 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
Trial design
Treatments tested in this trial
- Chia seeds
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oklahoma
Lead sponsor
Presbyterian Health Foundation
Collaborator
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov