Impact of Chia Seeds on Human Breast Milk Composition
Starting soon · Not applicable
Conditions studied: Obesity and Overweight, Breastfeeding, Exclusive
In brief
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).
Key facts
- Study ID
- NCT07343908
- Run by
- University of Oklahoma
- People needed
- 80
- Starts
- 2026-08-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- pre-pregnancy BMI >25 kg/m²
- 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
You may not qualify if…
- 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
- Taking Antibiotics (all), Proton pump inhibitors/H2 blockers, Metformin, NSAIDs, Statins, SSRIs and tricyclic antidepressants
Where it is running
- Brigham and Womens Hospital — Boston, Massachusetts, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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