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Completed

NCT Number: NCT03912038

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

General Hospital of Mexico Dr. Eduardo Liceaga

Mexico City, 06726, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention.

Other

No intervention

Primary outcomes

  1. Microbiota composition in feces

    Time frame: 2 months

    Composition of feces microbiota in mother and newborn

  2. Microbiota composition in feces

    Time frame: 4 months

    Composition of feces microbiota in mother and newborn

  3. Microbiota composition in feces

    Time frame: 6 months

    Composition of feces microbiota in mother and newborn

  4. Microbiota composition in breast milk

    Time frame: 0 months

    Composition of breast milk microbiota

  5. Microbiota composition in breast milk

    Time frame: 2 months

    Composition of breast milk microbiota

  6. Microbiota composition in breast milk

    Time frame: 4 months

    Composition of breast milk microbiota

  7. Microbiota composition in breast milk

    Time frame: 6 months

    Composition of breast milk microbiota

  8. Non-caloric sweeteners levels at birth

    Time frame: at birth

    Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL

  9. Non-caloric sweeteners levels 2 months follow-up

    Time frame: 2 months after birth

    Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up

  10. Non-caloric sweeteners levels 4 months follow-up

    Time frame: 4 months after birth

    Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up

  11. Non-caloric sweeteners levels 6 months follow-up

    Time frame: 6 months after birth

    Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up

Sponsors and collaborators

Lead sponsor

Hospital General de México Dr. Eduardo Liceaga

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2019
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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