Clinical trial NCT03912038: Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
Official title: Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Colonization
Keywords: Non-caloric sweeteners
microbiota
breast milk
umbilical cord
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2019-04-11
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor who come to the service of gynecology and obstetrics General Hospital Mexico. Usually, they are residents from Mexico City and metropolitan area (Mexico State).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Microbiota composition in feces
timeFrame: 2 months
measure: Microbiota composition in feces
timeFrame: 4 months
measure: Microbiota composition in feces
timeFrame: 6 months
measure: Microbiota composition in breast milk
timeFrame: 0 months
measure: Microbiota composition in breast milk
timeFrame: 2 months
measure: Microbiota composition in breast milk
timeFrame: 4 months
measure: Microbiota composition in breast milk
timeFrame: 6 months
measure: Non-caloric sweeteners levels at birth
timeFrame: at birth
measure: Non-caloric sweeteners levels 2 months follow-up
timeFrame: 2 months after birth
measure: Non-caloric sweeteners levels 4 months follow-up
timeFrame: 4 months after birth
measure: Non-caloric sweeteners levels 6 months follow-up
timeFrame: 6 months after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: General Hospital of Mexico Dr. Eduardo Liceaga
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Marcela Esquivel, PhD
role: PRINCIPAL_INVESTIGATOR
References: