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

NCT ID: NCT03912038

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 178 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2022-12-31

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.

Conditions

Microbial Colonization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Null or low consumption

No-intervention. The group consists of women who have reported a null or low consumption of non-caloric sweeteners during late pregnancy.

No intervention.

Intervention Type: OTHER

No intervention

Moderate consumption

No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy.

No intervention.

Intervention Type: OTHER

No intervention

High consumption

No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy.

No intervention.

Intervention Type: OTHER

No intervention

Interventions

No intervention.

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital General de México Dr. Eduardo Liceaga

OTHER_GOV

Sponsor Role: lead

Responsible Party

Marcela Esquivel V

Medical Sciences Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcela Esquivel, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de México Dr. Eduardo Liceaga

Locations

General Hospital of Mexico Dr. Eduardo Liceaga

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

DI/17/301/05/075

Identifier Type: -

Identifier Source: org_study_id