Impact of Chia Seeds on Human Breast Milk Composition

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Oklahoma
Study ID
NCT07343908
Status
Not Yet Recruiting

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Conditions

  • Breastfeeding, Exclusive
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Chia seeds — DIETARY_SUPPLEMENT
    Chia seeds will be given to lactating mothers.

Study Details

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 Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control - no intervention
    This arm is the control arm that will not receive food-based dietary intervention
  • Experimental: Chia Seeds
    This group will receive the food-based intervention

Primary Outcome Measure

Breast milk [ Time Frame: 6 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Womens HospitalBostonMassachusetts02115
Paige K Berger, Phd, RDN
[email protected]
617-525-4131
Paige K Berger, Phd, RDN (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
David A Fields, PhD
[email protected]
405-271-3093
Kathy Burge, Phd (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Womens Hospital· Boston, MAUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

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