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Impact of Chia Seeds on Human Breast Milk Composition

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07343908
Enrollment
80
Registered
2026-01-15
Start date
2026-08-01
Completion date
2027-12-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Exclusive, Obesity and Overweight

Keywords

Obesity and Overweight, Breastfeeding, Exclusive, Breastmilk, Body Composition, Infant Growth

Brief 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).

Detailed description

Childhood metabolic disease has become a progressively serious global health challenge. The investigators' preliminary data reveal maternal metabolic dysfunction and poor diet are associated with increased human milk fat, proinflammatory markers, and altered microbiota, potentially contributing to transmission of metabolic susceptibility to offspring, while their studies in animal models demonstrate associations between milk composition and offspring metabolic health may be a mechanism by which lactational programming dictates offspring metabolic susceptibility. The investigators' long-term goal is to identify easy-to-implement maternal dietary interventions to optimize offspring development and prevent childhood metabolic disease. Chia seeds contain fiber, polyphenols, -3 polyunsaturated fatty acids, and bioactive peptides, and, through a multitude of mechanisms, improve the metabolic health of those with type 2 diabetes and obesity. This project will test the hypotheses that (Aim 1) 6wks of chia seed supplementation will impact obese, lactating mothers' metabolic health, milk composition, and infant growth, and (Aim 2) chia seed polyphenols and bioactive peptides will reduce permeability, inflammation, and oxidative stress, as well as ATP generating metabolism, in human enteroids, at homeostasis and during in vitro lipotoxicity. Further, investigators will utilize a luciferase-reporter assay to evaluate whether chia seed bioactives function via activation of extraoral bitter taste receptors. Successful completion of this project will inform future maternal lactational interventions that are practical and effective in reducing offspring susceptibility to childhood obesity and diabetes, supporting feasibility for a multidisciplinary, collaborative grant focused on the metabolic health of mother-infant dyads.

Interventions

DIETARY_SUPPLEMENTChia seeds

Chia seeds will be given to lactating mothers.

Sponsors

University of Oklahoma
Lead SponsorOTHER
Presbyterian Health Foundation
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breast milk6 weeksBreast milk composition primarily macronutrient composition (total fat, total carbohydrate, total protein along with caloric density). Additionally, markers of inflammation (IL-6 and CRP) along with metabolic health (glucose and insulin) will be measured in milk from the collection of a complete breast expression (\~1 to 2 ounces).
Breast Milk6 weeksChanges in breast milk will be investigated (both macro nutrients and small bioactive). Macronutrient composition will encompass total fat, protein and carbohydrate, along with caloric density. Small bioactives will include glucose, insulin, CRP and IL-6. This will be measured by collecting breast milk from a complete breast expression (\~1 to 2 ounces).

Secondary

MeasureTime frameDescription
Maternal serum levels following 6 week Chia seed intervention6 weeksBaseline and 6 weeks post intervention maternal serum (\~5 ml) will be collected. Maternal serum will be measured for lipids (cholesterol, triglycerides, HDL, LDL) along with markers of inflammation (IL-6 and CRP) and metabolic health (insulin and glucose).

Countries

United States

Contacts

CONTACTDavid A Fields, PhD
david-fields@ou.edu405-271-2767
CONTACTKathy Burge, PhD
kathryn-burge@ou.edu405-271-5215
PRINCIPAL_INVESTIGATORDavid A Fields, PhD

University of Oklahoma

PRINCIPAL_INVESTIGATORKathy Burge, PhD

University of Oklahoma Health Sciences

PRINCIPAL_INVESTIGATORPaige H Berger, Phd, RDN

Brigham and Women's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026