Health TrialsbyHealthPanel

Impact of Chia Seeds on Human Breast Milk Composition

ConditionsObesity and OverweightBreastfeeding, Exclusive
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Oklahoma

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

pre-pregnancy BMI >25 kg/m²

Maternal age 18 - 45 years at time of delivery

Singleton pregnancy

Vaginal delivery

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chia seeds

    Dietary supplement

    Chia seeds will be given to lactating mothers.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control - no interventionNo intervention 0 interventions
Group B: Chia SeedsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6 weeks
2

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).

Time frame
6 weeks

Secondary outcomes

1

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).

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

Presbyterian Health Foundation

Collaborator

Brigham and Women's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: