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Impact of Chia Seeds on Human Breast Milk Composition and Offspring Metabolic Health

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Study Aim

This study aims to investigate how consuming chia seeds can affect the composition of human breast milk and the metabolic health of the nursing infant.

What is being tested

Chia seeds

Dietary Supplement
Who is being recruted

Behavior+8

+ Body Weight

+ Breast Feeding

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: March 2026
See protocol details

Summary

Principal SponsorUniversity of Oklahoma
Study ContactDavid A Fields, PhdMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2026

Actual date on which the first participant was enrolled.

Childhood metabolic diseases are a growing global health concern. Poor diet and metabolic dysfunction in mothers can lead to changes in breast milk, such as increased fat and altered microbiota, which may contribute to the development of metabolic diseases in their children. This study aims to find simple dietary changes that mothers can make to improve their children's health and prevent metabolic diseases. One potential solution being investigated is chia seeds, which contain beneficial nutrients like fiber, polyphenols, and omega-3 fatty acids. These nutrients have been shown to improve metabolic health in people with type 2 diabetes and obesity. The long-term goal of this research is to identify easy-to-implement dietary interventions for mothers to optimize their children's development and prevent childhood metabolic diseases. In this study, obese mothers who are breastfeeding will receive chia seed supplements for six weeks. The effects of these supplements on the mothers' metabolic health, breast milk composition, and infant growth will be evaluated. Additionally, the study will investigate how chia seed polyphenols and bioactive peptides affect human enteroids, which are small intestine cells grown in a lab. The researchers will look at whether these compounds can reduce inflammation, oxidative stress, and other factors that contribute to metabolic diseases. The study will also examine if chia seed bioactives work by activating extraoral bitter taste receptors. The successful completion of this project could lead to practical and effective maternal interventions that reduce the risk of childhood obesity and diabetes.

Official TitleAn RCT: Impact of Chia Seeds on Human Breast Milk Composition
Principal SponsorUniversity of Oklahoma
Study ContactDavid A Fields, PhdMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBody WeightBreast FeedingFeeding BehaviorNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This group will receive the food-based intervention

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Brigham and Womens Hospital

Boston, United StatesOpen Brigham and Womens Hospital in Google Maps
Suspended

University of Oklahoma Health Sciences Center

Oklahoma City, United States
Recruiting soon2 Study Centers