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临床试验/NCT03912038
NCT03912038已完成不适用

Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.

Hospital General de México Dr. Eduardo Liceaga1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2018年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
Non-caloric sweeteners levels at birth

研究概览

简要总结

This study evaluates the presence and quantity of non-caloric sweeteners in newborns umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months and 6 months of age. Microbiota composition will be evaluated in milk and in feces of both mother and child.

详细描述

The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as "diet". Despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent ENC users are also at risk of excessive weight gain, type II diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the early stages of life may predispose to the development of metabolic disorders later in life.The ENC have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of ENC consumption has not been investigated. This makes it relevant to study the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption of ENC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age 18-40 years old
  • Women in labor
  • Consent to participate in the study

排除标准

  • Pre-term delivery (<30 weeks)
  • Metabolic diseases (insulin resistance, diabetes, gestational diabetes)
  • Hypertension
  • Thyroid disease

结局指标

主要结局

Non-caloric sweeteners levels at birth

时间窗: at birth

Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL

Non-caloric sweeteners levels 4 months follow-up

时间窗: 4 months after birth

Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up

Microbiota composition in breast milk

时间窗: 6 months

Composition of breast milk microbiota

Microbiota composition in feces

时间窗: 6 months

Composition of feces microbiota in mother and newborn

Non-caloric sweeteners levels 2 months follow-up

时间窗: 2 months after birth

Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up

Non-caloric sweeteners levels 6 months follow-up

时间窗: 6 months after birth

Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Marcela Esquivel V

Medical Sciences Researcher

Hospital General de México Dr. Eduardo Liceaga

研究点 (1)

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