Clinical Trials Directory

Trials / Completed

CompletedNCT03912038

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

Status
Completed
Phase
Study type
Observational
Enrollment
178 (actual)
Sponsor
Hospital General de México Dr. Eduardo Liceaga · Other Government
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNo intervention.No intervention

Timeline

Start date
2018-01-26
Primary completion
2022-12-31
Completion
2022-12-31
First posted
2019-04-11
Last updated
2023-09-21

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT03912038. Inclusion in this directory is not an endorsement.