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临床试验/NCT07343908
NCT07343908尚未招募不适用

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

University of Oklahoma2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年8月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2
主要终点
Breast milk

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Chia seeds (Dietary Supplement)

结局指标

主要结局

Breast milk

时间窗: 6 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 Milk

时间窗: 6 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).

次要结局

  • Maternal serum levels following 6 week Chia seed intervention(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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