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NOT YET RECRUITING
NCT07343908
NA

Impact of Chia Seeds on Human Breast Milk Composition

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03

Completion Date

2027-12

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Chia seeds

Chia seeds will be given to lactating mothers.

Locations (2)

Brigham and Womens Hospital

Boston, Massachusetts, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States