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

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912038
• Other study ID #: DI/17/301/05/075
• Status: Completed
• Start date: January 26, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2023
• Source: Hospital General de México Dr. Eduardo Liceaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Other:
• No intervention.
No intervention

Locations

Country	Name	City	State
Mexico	General Hospital of Mexico Dr. Eduardo Liceaga	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de México Dr. Eduardo Liceaga

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota composition in feces	Composition of feces microbiota in mother and newborn	2 months
Primary	Microbiota composition in feces	Composition of feces microbiota in mother and newborn	4 months
Primary	Microbiota composition in feces	Composition of feces microbiota in mother and newborn	6 months
Primary	Microbiota composition in breast milk	Composition of breast milk microbiota	0 months
Primary	Microbiota composition in breast milk	Composition of breast milk microbiota	2 months
Primary	Microbiota composition in breast milk	Composition of breast milk microbiota	4 months
Primary	Microbiota composition in breast milk	Composition of breast milk microbiota	6 months
Primary	Non-caloric sweeteners levels at birth	Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL	at birth
Primary	Non-caloric sweeteners levels 2 months follow-up	Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up	2 months after birth
Primary	Non-caloric sweeteners levels 4 months follow-up	Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up	4 months after birth
Primary	Non-caloric sweeteners levels 6 months follow-up	Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up	6 months after birth