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Chia seeds and breast milk in breastfeeding mothers with overweight or obesity

Tests chia seeds eaten during breastfeeding by mothers with overweight or obesity.

Key facts

Who runs it
University of Oklahoma
Where
Boston and Oklahoma City, United StatesSee the 2 sites
Trial code
Registry title
Impact of Chia Seeds on Human Breast Milk Composition
Status
Not yet recruiting
People taking part
80 people, planned
Started
Aug 2026
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Chia seeds
Record updated
15 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for new mothers who gave birth vaginally, plan to breastfeed, and had a pre-pregnancy BMI above 25 kg/m². It tests chia seeds during breastfeeding.

Age
18 - 45 years at the time of delivery
Sex
All
Disease stage
Pre-pregnancy BMI above 25 kg/m²; singleton pregnancy; vaginal delivery.
Earlier treatment
No antibiotics for at least 1 week before each visit. No prescription medicines that may interfere with the gut microbiome. No chia seed supplements during pregnancy.

Main reasons for not taking part

  • Cannot understand English
  • Birth before 37 weeks or after 42 weeks
  • Condition or defect that affects milk production, infant growth or breastfeeding
  • Infant drinks more than 12 ounces of any liquid other than breast milk in the two weeks before each visit
  • Taking antibiotics, proton pump inhibitors/H2 blockers, metformin, NSAIDs, statins, SSRIs or tricyclic antidepressants

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Preterm or post-term birth (gestational age <37 or >42 weeks)
  • Inability to understand English

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Where in United States

  • Brigham and Womens HospitalBoston, United StatesContact: Paige K Berger, Phd, RDNNot yet recruiting
  • University of Oklahoma Health Sciences CenterOklahoma City, United StatesContact: David A Fields, PhDNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Control - no interventionNo study treatment, for comparison

    This arm is the control arm that will not receive food-based dietary intervention

  • Chia SeedsTreatment being tested

    This group will receive the food-based intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An RCT: Impact of Chia Seeds on Human Breast Milk Composition
Plain-language title
Chia seeds and breast milk in breastfeeding mothers with overweight or obesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07343908, who can take part
Record updated
15 May 2026