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
| Type | Name | Description |
|---|---|---|
| OTHER | No 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.