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

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.

Study Overview

• Status: Completed
• Conditions: Microbial Colonization
• Intervention / Treatment: Other: No intervention.

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 Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06726
    • General Hospital of Mexico Dr. Eduardo Liceaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women in labor who come to the service of gynecology and obstetrics General Hospital Mexico. Usually, they are residents from Mexico City and metropolitan area (Mexico State).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention.; No intervention
Moderate consumption; No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy.	Other: No intervention.; No intervention
High consumption; No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy.	Other: No intervention.; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota composition in feces	Composition of feces microbiota in mother and newborn	2 months
Microbiota composition in feces	Composition of feces microbiota in mother and newborn	4 months
Microbiota composition in feces	Composition of feces microbiota in mother and newborn	6 months
Microbiota composition in breast milk	Composition of breast milk microbiota	0 months
Microbiota composition in breast milk	Composition of breast milk microbiota	2 months
Microbiota composition in breast milk	Composition of breast milk microbiota	4 months
Microbiota composition in breast milk	Composition of breast milk microbiota	6 months
Non-caloric sweeteners levels at birth	Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL	at birth
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
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
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

Collaborators and Investigators

• Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Investigators: Principal Investigator: Marcela Esquivel, PhD, Hospital General de México Dr. Eduardo Liceaga

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: microbiota; breast milk; umbilical cord; Non-caloric sweeteners
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: DI/17/301/05/075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No