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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03912038
Other study ID # DI/17/301/05/075
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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