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

Completed

• Conditions: Microbial Colonization
• Interventions: Other: No intervention.

• Registration Number: NCT03912038
• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga

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.

Study Timeline

• Study Start: 2018-01-26
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 178

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Null or low consumption	No intervention.	No-intervention. The group consists of women who have reported a null or low consumption of non-caloric sweeteners during late pregnancy.
Moderate consumption	No intervention.	No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy.
High consumption	No intervention.	No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy.

Primary Outcome Measures

Name	Time	Method
Microbiota composition in breast milk	6 months	Composition of breast milk microbiota
Non-caloric sweeteners levels at birth	at birth	Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL
Non-caloric sweeteners levels 4 months follow-up	4 months after birth	Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up
Microbiota composition in feces	6 months	Composition of feces microbiota in mother and newborn
Non-caloric sweeteners levels 2 months follow-up	2 months after birth	Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up
Non-caloric sweeteners levels 6 months follow-up	6 months after birth	Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up

Trial Locations

Locations (1)

General Hospital of Mexico Dr. Eduardo Liceaga; 🇲🇽 Mexico City, Mexico