NCT07343908Not yet recruiting
Impact of Chia Seeds on Human Breast Milk Composition
An RCT: Impact of Chia Seeds on Human Breast Milk Composition
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- Aug 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Oklahoma
- Diseases
- Obesity
- NCT number
- NCT07343908
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Aug 2026 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Age
- Preterm or post-term birth (gestational age \<37 or \>42 weeks)
Other
- Inability to understand English
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Womens Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.