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临床试验/NCT03972176
NCT03972176Unknown不适用

Determination of Perinatal Exposure to Non-caloric Sweeteners. Implications for the Development of Preferences for Sweet Taste, and Weight Gain During the First Year of Life

University of Chile0 个研究点目标入组 315 人开始时间: 2019年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
315
主要终点
Mothers with breastmilk NCSs

研究概览

简要总结

During last years, non-caloric sweeteners (NCSs) have been increasingly incorporated into foodstuffs in replacement of sucrose in Chile. This situation has reached a point where it is currently difficult to find sugary foods without NCSs. As a result, the voluntary and involuntary consumption of these additives is growing significantly in the population, increasing the risk of exceeding the acceptable daily intake (ADI), especially for children. This situation is worrying as recent evidence suggests that NCSs are not inert in the body and can trigger adverse metabolic effects. For example, the consumption of beverages with NCSs has been shown to favor the development of obesity and type-2 diabetes in children and adults, and a recent study reported that the intake of NCSs during pregnancy was associated with a greater weight gain of the child at one year. It is likely that certain NCSs pass into the amniotic fluid and that the fetus is exposed to some of these compounds during pregnancy. This situation would persist in the infant through breast milk, as some studies detected sucralose and acesulfame-K in this fluid, even in mothers who claimed not to consume them. However, the real impact of NCS exposure during the neonatal period on the child health has been few studied. Therefore, the aim of this study is to determine the concentration of NCSs in samples of amniotic liquid and breastmilk and to correlate these data with the NCS intake by the mothers. Mothers/children will be classified in quintiles according to the results obtained. In the children from quintiles 1 and 5, we will also study whether neonatal exposure to NCSs may affect the sweet taste threshold and the preferences for this taste, the levels of salivary insulin and the weight gain in the first year. Breastmilk microbiota and child fecal microbiota will be also evaluated.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Women with at least 36 weeks of gestation
  • Spanish-speaking
  • Elective cesarean delivery

排除标准

  • Multiple pregnancy
  • Type-2 diabetes
  • Intelectual disability
  • Presence of infectious disease compatible with chorio-amnionitis or immunosupression
  • Newborns with serious pathologies affecting their growth

结局指标

主要结局

Mothers with breastmilk NCSs

时间窗: One month post-partum

Proportion of mothers with detectable NCSs in their breastmilk

次要结局

  • Mothers with amniotic liquid NCSs(At delivery)
  • Breastmilk concentrations of NCSs(One month post-partum)
  • Salivary insulin in children(6 months)
  • Sweet taste of amniotic liquid(At delivery)
  • Food preferences in children(At 6 month of age)
  • Infant gain weight(At 12 months)
  • Pregnancy complications(At delivery)
  • Breast milk microbiota diversity(At one month post-partum)
  • Breast milk microbiota composition(At one month post-partum)
  • Consumption of NCSs by the mothers(At recruitment (in the last month of pregnancy) and at 1 mont post-partum)
  • Amniotic liquid concentrations of NCSs(At delivery)
  • Polymorphism of sweet taste receptor in children(At six months post-partum)
  • Threshold of sweet taste in children(6 months)
  • Sweet taste of breastmilk(One month post-partum)
  • Fecal microbiota composition in children(At six months post-partum)
  • Fecal microbiota diversity in children(At six months post-partum)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Gotteland

Head, Lab. of Digestive Physiology

University of Chile

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