Impact of Chia Seeds on Human Breast Milk Composition

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Breastfeeding, Exclusive; Obesity and Overweight
• Intervention / Treatment: Dietary supplement: Chia seeds

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Fields, PhD; Phone Number: 405-271-2767; Email: david-fields@ou.edu
• Study Contact Backup: Name: Kathy Burge, PhD; Phone Number: 405-271-5215; Email: kathryn-burge@ou.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
      • Contact: Paige K Berger, Phd, RDN; Phone Number: 617-525-4131; Email: pberger@bwh.harvard.edu
      • Principal Investigator: Paige K Berger, Phd, RDN
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
      • Contact: David A Fields, PhD; Phone Number: 405-271-3093; Email: david-fields@ou.edu
      • Principal Investigator: Kathy Burge, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Dietary supplement: Chia seeds; Chia seeds will be given to lactating mothers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast milk	Breast 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).	6 weeks
Breast Milk	Changes 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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal serum levels following 6 week Chia seed intervention	Baseline 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).	6 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Brigham and Women's Hospital; Presbyterian Health Foundation
• Investigators: Principal Investigator: David A Fields, PhD, University of Oklahoma; Principal Investigator: Kathy Burge, PhD, University of Oklahoma Health Sciences; Principal Investigator: Paige H Berger, Phd, RDN, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Body Composition; Breastmilk; Infant Growth; Breastfeeding, Exclusive; Obesity and Overweight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Overweight; Obesity; Breast Feeding
• Other Study ID Numbers: Chia Impact

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No