Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03912038
Enrollment
178
Registered
2019-04-11
Start date
2018-01-26
Completion date
2022-12-31
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

Keywords

Non-caloric sweeteners, microbiota, breast milk, umbilical cord

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.

Interventions

OTHERNo intervention.

No intervention

Sponsors

Hospital General de México Dr. Eduardo Liceaga
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiota composition in feces2 monthsComposition of feces microbiota in mother and newborn
Microbiota composition in breast milk0 monthsComposition of breast milk microbiota
Non-caloric sweeteners levels at birthat birthNon-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL
Non-caloric sweeteners levels 2 months follow-up2 months after birthNon-caloric sweeteners levels in breast milk and urine in the 2 months follow-up
Non-caloric sweeteners levels 4 months follow-up4 months after birthNon-caloric sweeteners levels in breast milk and urine in the 4 months follow-up
Non-caloric sweeteners levels 6 months follow-up6 months after birthNon-caloric sweeteners levels in breast milk and urine in the 6 months follow-up

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026