Chia Seeds for Breastfeeding

Not yet recruiting at 1 trial location
KB
DA
Overseen ByDavid A Fields, Phd
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

DA

David A Fields, Phd

Principal Investigator

University of Oklahoma

KB

Kathy Burge, Phd

Principal Investigator

University of Oklahoma Health Sciences

PH

Paige H Berger, Phd, RDN

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for mothers aged 18-45 with a pre-pregnancy BMI over 25, who had a vaginal delivery of one baby and plan to breastfeed for at least three months. They shouldn't have taken antibiotics within a week before visits or chia seed supplements during pregnancy.

Inclusion Criteria

I have not taken chia seed supplements during pregnancy.
I am between 18 and 45 years old and pregnant.
I am pregnant with one baby.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chia seed supplementation during lactation to evaluate its impact on metabolic health, milk composition, and infant growth

6 weeks
Regular visits for breast milk and serum collection

Follow-up

Participants are monitored for changes in breast milk composition and maternal serum levels post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Chia Seeds

Trial Overview

The study tests if adding chia seeds to the diet of breastfeeding mothers can reduce obesity-related inflammation in their gut and improve the composition of their breast milk, potentially benefiting infant growth and body composition.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Chia SeedsExperimental Treatment1 Intervention
Group II: Control - no interventionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Presbyterian Health Foundation

Collaborator

Trials
2
Recruited
80+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+