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Impact of Chia Seeds on Human Breast Milk Composition

An RCT: Impact of Chia Seeds on Human Breast Milk Composition

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (2)

MA

OK