Clinical trial

Impact of Chia Seeds on Human Breast Milk Composition

Opening soon · Not applicable · 1 countries · Registry ID NCT07343908

Opening soonNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity and Overweight, Breastfeeding, Exclusive

Full registry 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

Treatments and study arms

Chia seeds

Dietary Supplement

Chia seeds will be given to lactating mothers.

Primary outcomes

Breast milk6 weeks

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).

Breast Milk6 weeks

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).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Brigham and Womens Hospital🇺🇸 Boston, Massachusetts, United States

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Paige K Berger, Phd, RDNContact

Email · Call 617-525-4131

Paige K Berger, Phd, RDNPrincipal Investigator

University of Oklahoma Health Sciences Center🇺🇸 Oklahoma City, Oklahoma, United States

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David A Fields, PhDContact

Email · Call 405-271-3093

Kathy Burge, PhdPrincipal Investigator