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Impact of Chia Seeds on Human Breast Milk Composition

NCT07343908 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-15

No results posted yet for this study

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).

Conditions

  • Obesity and Overweight
  • Breastfeeding, Exclusive

Interventions

DIETARY_SUPPLEMENT

Chia seeds

Chia seeds will be given to lactating mothers.

Sponsors & Collaborators

  • Presbyterian Health Foundation

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • David A Fields, PhD · University of Oklahoma

  • Kathy Burge, PhD · University of Oklahoma Health Sciences

  • Paige H Berger, Phd, RDN · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343908 on ClinicalTrials.gov