NCT07343908

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

December 19, 2025

Last Update Submit

April 27, 2026

Conditions

Obesity and OverweightBreastfeeding, Exclusive

Keywords

Obesity and OverweightBreastfeeding, ExclusiveBreastmilkBody CompositionInfant Growth

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Maternal serum levels following 6 week Chia seed intervention

    6 weeks

Study Arms (2)

Control - no intervention

NO INTERVENTION

This arm is the control arm that will not receive food-based dietary intervention

Chia Seeds

EXPERIMENTAL

This group will receive the food-based intervention

Dietary Supplement: Chia seeds

Interventions

Chia seedsDIETARY_SUPPLEMENT

Chia seeds will be given to lactating mothers.

Chia Seeds

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

ObesityOverweightBreast Feeding

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Fields, Phd

CONTACT

405-271-2767david-fields@ou.edu

Kathy Burge, Phd

CONTACT

405-271-5215kathryn-burge@ou.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 15, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)