Impact of Chia Seeds on Human Breast Milk Composition (NCT07343908) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Chia Seeds on Human Breast Milk Composition
United States80 participantsStarted 2026-08
Plain-language summary
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).
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.